The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER) (OCTOBER)

May 13, 2026 updated by: Evald Hoej Christiansen, Aarhus University Hospital Skejby

European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.

It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.

Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.

Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.

Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg (ZOL) Genk
      • Leuven, Belgium, 3000
        • Leuven University Hospital
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg University Hospital
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital Skejby
      • Gentofte Municipality, Denmark, 2820
        • Gentofte Hospital
      • København Ø, Denmark, 2100
        • Rigshospitalet
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Zealand University Hospital, Roskilde Sygehus
  • Estonia
      • Tallinn, Estonia, 13419
        • Estonia Medical Centre
  • Finland
      • Tampere, Finland, 33520
        • Tampere University Hospital
  • Germany
      • Hamburg, Germany, 20246
        • Universitäres Herzzentrum Hamburg
      • Hamburg, Germany, 22041
        • Cardiologicum Hamburg
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain
  • Ireland
      • Galway, Ireland, H91YR71
        • University Hospital Galway
  • Italy
      • Rome, Italy, 00168
        • Gemelli General Hospital, Catholic University of the Sacred Heart
    • Cona
      • Ferrara, Cona, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara
  • Latvia
      • Riga, Latvia, LV-1002
        • Latvia Centre of Cardiology
  • Netherlands
      • Alkmaar, Netherlands, 1815
        • Northwest Hospital Alkmaar
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center (VUMC)
      • Nieuwegein, Netherlands, 3435 CM
        • St Antonius Ziekenhuis
  • Norway
      • Arendal, Norway, 4604
        • Hospital of Southern Norway, Arendal
      • Bergen, Norway
        • Haukeland University Hospital, Bergen
      • Oslo, Norway, 0424
        • Oslo University Hospital, Rikshospitalet
      • Oslo, Norway, 0450
        • Oslo University Hospital - Ullevål
      • Trondheim, Norway
        • Trondheim University Hospital
  • Poland
      • Warsaw, Poland, 02-097
        • Medical University of Warsaw
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital
      • Stockholm, Sweden, 118 83
        • Södersjukhuset
      • Örebro, Sweden, 70185
        • Orebro University Hospital
    • Stockholm County
      • Huddinge, Stockholm County, Sweden, 14157
        • Karolinska University Hospital Huddinge
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast Health and Social Care Trust
      • Bournemouth, United Kingdom, BH77DW
        • Royal Bournemouth Hospital
      • Brighton, United Kingdom, BN2 5BE
        • Sussex Cardiac Centre
      • Glasgow, United Kingdom, G81 4DY
        • Golden Jubilee Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • Manchester, United Kingdom, M239LT
        • University Hospital South Manchester, Wythenshawe Hospital
      • Swansea, United Kingdom, SA6 6NL
        • Morriston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
  • Age ≥18 yrs.
  • Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.

Angiographic inclusion criteria:

  • Native coronary bifurcation de novo lesion
  • More than 50% diameter stenosis in the main vessel (MV)
  • More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
  • Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.

Functional inclusion criteria:

Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.

Procedural inclusion criteria:

Indication for two-stent technique or one-stent technique with kissing balloon inflation

Exclusion Criteria:

  • STEMI within 72 hours
  • Cardiogenic shock
  • Prior coronary artery bypass grafting (CABG) or planned CABG
  • Renal failure with glomerular filtration rate (GFR) <50 mL/min per 1.73 m2
  • Active bleeding or coagulopathy
  • Life expectancy < 2 years
  • Ejection fraction < 30%
  • New York Heart Association (NYHA) class > II
  • Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).

Angiographic exclusion criteria:

  • Severe tortuosity around target bifurcation
  • Chronic total occlusions
  • Massive thrombus in Left main coronary artery
  • Medina 0.0.1 lesions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Angiographic guided PCI
Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
Procedure: Angiographic guided PCI
Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
Other Names:
  • PCI, percutaneous transluminal coronary angioplasty (PTCA)
Experimental: OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Procedure: OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
Other Names:
  • OCT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Combined endpoint of major adverse cardiac events (MACE)
Time Frame: 24 months
Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 1 month
Death of any cause including cardiac deaths and non-natural causes of death
1 month
All-cause mortality
Time Frame: 12 months
Death of any cause including cardiac deaths and non-natural causes of death
12 months
All-cause mortality
Time Frame: 24 months
Death of any cause including cardiac deaths and non-natural causes of death
24 months
All-cause mortality
Time Frame: 36 months
Death of any cause including cardiac deaths and non-natural causes of death
36 months
All-cause mortality
Time Frame: 48 months
Death of any cause including cardiac deaths and non-natural causes of death
48 months
All-cause mortality
Time Frame: 60 months
Death of any cause including cardiac deaths and non-natural causes of death
60 months
All-cause mortality
Time Frame: 120 months
Death of any cause including cardiac deaths and non-natural causes of death
120 months
Myocardial infarction
Time Frame: 1 month
Procedure and non-procedure related myocardial infarction
1 month
Myocardial infarction
Time Frame: 12 months
Procedure and non-procedure related myocardial infarction
12 months
Myocardial infarction
Time Frame: 24 months
Procedure and non-procedure related myocardial infarction
24 months
Myocardial infarction
Time Frame: 36 months
Procedure and non-procedure related myocardial infarction
36 months
Myocardial infarction
Time Frame: 48 months
Procedure and non-procedure related myocardial infarction
48 months
Myocardial infarction
Time Frame: 60 months
Procedure and non-procedure related myocardial infarction
60 months
Stent Thrombosis
Time Frame: 1 month
Definite, possible or probable
1 month
Stent Thrombosis
Time Frame: 12 months
Definite, possible or probable
12 months
Stent Thrombosis
Time Frame: 24 months
Definite, possible or probable
24 months
Stent Thrombosis
Time Frame: 36 months
Definite, possible or probable
36 months
Stent Thrombosis
Time Frame: 48 months
Definite, possible or probable
48 months
Stent Thrombosis
Time Frame: 60 months
Definite, possible or probable
60 months
Target lesion myocardial infarction
Time Frame: 1 month
Myocardial infarction related to an index treated lesion
1 month
Target lesion myocardial infarction
Time Frame: 12 months
Myocardial infarction related to an index treated lesion
12 months
Target lesion myocardial infarction
Time Frame: 24 months
Myocardial infarction related to an index treated lesion
24 months
Target lesion myocardial infarction
Time Frame: 36 months
Myocardial infarction related to an index treated lesion
36 months
Target lesion myocardial infarction
Time Frame: 48 months
Myocardial infarction related to an index treated lesion
48 months
Target lesion myocardial infarction
Time Frame: 60 months
Myocardial infarction related to an index treated lesion
60 months
Target bifurcation myocardial infarction
Time Frame: 1 month
Myocardial infarction related to the index bifurcation
1 month
Target bifurcation myocardial infarction
Time Frame: 12 months
Myocardial infarction related to the index bifurcation
12 months
Target bifurcation myocardial infarction
Time Frame: 24 months
Myocardial infarction related to the index bifurcation
24 months
Target bifurcation myocardial infarction
Time Frame: 36 months
Myocardial infarction related to the index bifurcation
36 months
Target bifurcation myocardial infarction
Time Frame: 48 months
Myocardial infarction related to the index bifurcation
48 months
Target bifurcation myocardial infarction
Time Frame: 60 months
Myocardial infarction related to the index bifurcation
60 months
CCS angina class
Time Frame: 1 month
Canadian Cardiovascular Society (CCS) grading of angina pectoris
1 month
CCS angina class
Time Frame: 12 months
Canadian Cardiovascular Society (CCS) grading of angina pectoris
12 months
CCS angina class
Time Frame: 24 months
Canadian Cardiovascular Society (CCS) grading of angina pectoris
24 months
CCS angina class
Time Frame: 36 months
Canadian Cardiovascular Society (CCS) grading of angina pectoris
36 months
CCS angina class
Time Frame: 48 months
Canadian Cardiovascular Society (CCS) grading of angina pectoris
48 months
CCS angina class
Time Frame: 60 months
Canadian Cardiovascular Society (CCS) grading of angina pectoris
60 months
Study bifurcation oriented composite endpoint
Time Frame: 1 month
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
1 month
Study bifurcation oriented composite endpoint
Time Frame: 12 months
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
12 months
Study bifurcation oriented composite endpoint
Time Frame: 24 months
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
24 months
Study bifurcation oriented composite endpoint
Time Frame: 36 months
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
36 months
Study bifurcation oriented composite endpoint
Time Frame: 48 months
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
48 months
Study bifurcation oriented composite endpoint
Time Frame: 60 months
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
60 months
Patient oriented composite endpoint
Time Frame: 1 month
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
1 month
Patient oriented composite endpoint
Time Frame: 12 months
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
12 months
Patient oriented composite endpoint
Time Frame: 24 months
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
24 months
Patient oriented composite endpoint
Time Frame: 36 months
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
36 months
Patient oriented composite endpoint
Time Frame: 48 months
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
48 months
Patient oriented composite endpoint
Time Frame: 60 months
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
60 months
Cardiac death
Time Frame: 1 month
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
1 month
Cardiac death
Time Frame: 12 months
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
12 months
Cardiac death
Time Frame: 24 months
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
24 months
Cardiac death
Time Frame: 36 months
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
36 months
Cardiac death
Time Frame: 48 months
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
48 months
Cardiac death
Time Frame: 60 months
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
60 months
Target lesion revascularisation
Time Frame: 1 month
Coronary artery bypass grafting or PCI of target lesion
1 month
Target lesion revascularisation
Time Frame: 12 months
Coronary artery bypass grafting or PCI of target lesion
12 months
Target lesion revascularisation
Time Frame: 24 months
Coronary artery bypass grafting or PCI of target lesion
24 months
Target lesion revascularisation
Time Frame: 36 months
Coronary artery bypass grafting or PCI of target lesion
36 months
Target lesion revascularisation
Time Frame: 48 months
Coronary artery bypass grafting or PCI of target lesion
48 months
Target lesion revascularisation
Time Frame: 60 months
Coronary artery bypass grafting or PCI of target lesion
60 months
Target bifurcation revascularisation
Time Frame: 1 month
Coronary artery bypass grafting or PCI of target bifurcation
1 month
Target bifurcation revascularisation
Time Frame: 12 months
Coronary artery bypass grafting or PCI of target bifurcation
12 months
Target bifurcation revascularisation
Time Frame: 24 months
Coronary artery bypass grafting or PCI of target bifurcation
24 months
Target bifurcation revascularisation
Time Frame: 36 months
Coronary artery bypass grafting or PCI of target bifurcation
36 months
Target bifurcation revascularisation
Time Frame: 48 months
Coronary artery bypass grafting or PCI of target bifurcation
48 months
Target bifurcation revascularisation
Time Frame: 60 months
Coronary artery bypass grafting or PCI of target bifurcation
60 months
Target vessel revascularisation
Time Frame: 1 month
Coronary artery bypass grafting or PCI of target vessel
1 month
Target vessel revascularisation
Time Frame: 12 months
Coronary artery bypass grafting or PCI of target vessel
12 months
Target vessel revascularisation
Time Frame: 24 months
Coronary artery bypass grafting or PCI of target vessel
24 months
Target vessel revascularisation
Time Frame: 36 months
Coronary artery bypass grafting or PCI of target vessel
36 months
Target vessel revascularisation
Time Frame: 48 months
Coronary artery bypass grafting or PCI of target vessel
48 months
Target vessel revascularisation
Time Frame: 60 months
Coronary artery bypass grafting or PCI of target vessel
60 months
Any revascularisation
Time Frame: 1 month
Any repeat revascularization except staged revascularization planned during the index procedure
1 month
Any revascularisation
Time Frame: 12 months
Any repeat revascularization except staged revascularization planned during the index procedure
12 months
Any revascularisation
Time Frame: 24 months
Any repeat revascularization except staged revascularization planned during the index procedure
24 months
Any revascularisation
Time Frame: 36 months
Any repeat revascularization except staged revascularization planned during the index procedure
36 months
Any revascularisation
Time Frame: 48 months
Any repeat revascularization except staged revascularization planned during the index procedure
48 months
Any revascularisation
Time Frame: 60 months
Any repeat revascularization except staged revascularization planned during the index procedure
60 months
Contrast volume
Time Frame: Baseline, after final baseline procedure
Contrast volume
Baseline, after final baseline procedure
Procedure time
Time Frame: Baseline, after final baseline procedure
Procedure time
Baseline, after final baseline procedure
Fluoroscopy time
Time Frame: Baseline, after final baseline procedure
Fluoroscopy time
Baseline, after final baseline procedure
Number of stents implanted in target lesion
Time Frame: Baseline, after final baseline procedure
Number of stents implanted in target lesion
Baseline, after final baseline procedure
Number of stents implanted in non-target lesion
Time Frame: Baseline, after final baseline procedure
Number of stents implanted in non-target lesion
Baseline, after final baseline procedure
Total stent length in target lesion
Time Frame: Baseline, just after final baseline procedure
Total stent length in target lesion
Baseline, just after final baseline procedure
Total stent length in total
Time Frame: Baseline, just after final baseline procedure
Total stent length in total
Baseline, just after final baseline procedure
Procedural success
Time Frame: Baseline, just after final baseline procedure
TIMI III flow and less than 30% diameter stenosis in target segments
Baseline, just after final baseline procedure
OCT-guiding group: Successful final OCT acquisition in MV
Time Frame: Baseline, just after final baseline procedure
For OCT-guided enrollments. Successful final OCT acquisition in main vessel. Success defined as analyzable stented segment.
Baseline, just after final baseline procedure
OCT-guiding group: Successful final OCT acquisition in SB
Time Frame: Baseline, just after final baseline procedure
For OCT-guided enrollments. Successful final OCT acquisition in side branch. Success defined as analyzable stented segment.
Baseline, just after final baseline procedure
OCT-guiding group: Successful treatment specific OCT acquisitions
Time Frame: Baseline, after final baseline procedure
OCT performed succesfully in protocol-defined vessels at all protocol-defined time-points during baseline procedure
Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the stented proximal main vessel segment
Time Frame: Baseline, after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the stented distal main vessel segment
Time Frame: Baseline, after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment
Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the treated side branch vessel segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the proximal main vessel edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the distal main vessel edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the side branch vessel edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the stented bifurcation core segment
Time Frame: Baseline, after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment
Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented proximal main vessel segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented distal main vessel segment
Time Frame: Baseline, after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment
Baseline, after final baseline procedure
Post-PCI diameter stenosis in the treated side branch vessel segment
Time Frame: Baseline, after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
Baseline, after final baseline procedure
Post-PCI diameter stenosis in the proximal main vessel edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the distal main vessel edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the side branch vessel edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented bifurcation core segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the stented distal main vessel ostium segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in the treated side branch ostium segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment
Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter in non-bifurcation target stented segment
Time Frame: Baseline, after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment
Time Frame: Baseline, after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)
Baseline, after final baseline procedure
Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in non-bifurcation target stented segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in non-bifurcation target proximal edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment
Baseline, just after final baseline procedure
Post-PCI diameter stenosis in non-bifurcation target distal edge segment
Time Frame: Baseline, just after final baseline procedure
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment
Baseline, just after final baseline procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital Skejby

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Evald H Christiansen, MD, PhD, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 25, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-10-72-161-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Is decided after primary endpoint assessment and requires regulatory approval

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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