- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03625908
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
November 9, 2023 updated by: Yonsei University
There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT.
In the study, we will explore the clinical implication of OCT-guided PCI of complex lesions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Eligible patients will be randomly assigned to either OCT-guided PCI arm and angiography-guided PCI with routine high pressure NC ballooning arm in 1:1 ratio.
Within OCT-guided PCI arm, the use of OCT will be also assigned to full OCT-guidance arm and postprocedural OCT only arm.
and comparison of stent implantation with and without preprocedural OCT will be evaluated by postprocedural OCT (OCT-defined stent optimization will be assessed).
In angiography-guided PCI arm, PCI for complex lesion will be performed without guidance of intravascular imaging, and routine use of high pressure postdilation with NC balloon will be also recommended.
Primary endpoint will be evaluated during 12 months after PCI.
Study Type
Interventional
Enrollment (Actual)
1604
Phase
- 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
- Name: Yang Soo Jang, MD, Ph.D
- Phone Number: +82-2-2228-8210
- Email: jangys1212@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Yonsei Cardiovascular Center and Cardiovascular Research Institute, Yonsei University College of Medicine
-
-
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
Ages Eligible for Study
19 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion criteria
- Age 19-85 years
- Patients with ischemic heart diseases (including stable angina, unstable angina and acute myocardial infarction) presented with typical chest pain or objective evidences of myocardial ischemia (positive invasive or non-invasive studies, electrocardiogram (ECG) consistent with ischemia, or elevated cardiac enzymes)
- Complex coronary stenotic lesions (>50% based on visual estimate) considered for coronary revascularization with DES
Definition of complex lesions (at least one):
- Acute myocardial infarction
- Chronic total occlusion
- Long lesion: expected stent length ≥28mm based on angiographic estimation
- Calcified lesion
- Bifurcation (including all techniques, one- or two-stent)
- Unprotected left main disease
- Small vessel diseases with reference vessel diameter less than 2.5 mm
- Intracoronary thrombus visible on the angiography
- Stent thrombosis
- In-stent restenosis
- Bypass graft lesion
- Patients who provide signed informed consent
Exclusion criteria
- Severe hepatic dysfunction (≥3 times normal reference values)
- Significant renal dysfunction (Serum creatinine >2.0 mg/dL)
- Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, hemoglobin <8.0 g/dL, or other known bleeding diathesis
- Hemodynamically unstable during procedures or cardiogenic shock
- Pregnant women or women who might be pregnant
- Life expectancy; less than 1 year
- Inability to understand or read the informed content
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: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: OCT-guided PCI
Patients will receive PCI under OCT-guidance.
|
Patients will receive PCI under OCT-guidance.
Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.
|
Active Comparator: Angiography-guided PCI
Patients will receive PCI under Angiography-guidance.
|
Stent optimization using high-pressure non-compliance balloon will be highly recommend.
Balloon size would not be less than the stent diameter.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of major adverse cardiac events (MACEs)
Time Frame: 1 year
|
Composite of major adverse cardiac events (MACEs) - for comparison between OCT-guided PCI vs. angiography-guided PCI
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Each component of MACE
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
MACE = composite of cardiac death, myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization
|
1 year (except periprocedural MI - within 48 hours)
|
Any revascularization
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
1 year (except periprocedural MI - within 48 hours)
|
|
Target lesion revascularization
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
1 year (except periprocedural MI - within 48 hours)
|
|
Periprocedural myocardial infarction
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
Periprocedural MI - PCI-related myocardial infarction (>5x or >10x ULN)
|
1 year (except periprocedural MI - within 48 hours)
|
Bleeding
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
Bleeding defined by BARC and TIMI criteria
|
1 year (except periprocedural MI - within 48 hours)
|
Stroke
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
1 year (except periprocedural MI - within 48 hours)
|
|
Contrast-induced Nephropathy
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
1 year (except periprocedural MI - within 48 hours)
|
|
Stent optimization confirmed by OCT
Time Frame: 1 year (except periprocedural MI - within 48 hours)
|
The attainment(optimal or acceptable) of criteria regarding stent expansion is strongly recommended. As for the other criteria, further procedures could be decided by the operators' decisions considering the situations.
|
1 year (except periprocedural MI - within 48 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 9, 2019
Primary Completion (Actual)
October 12, 2023
Study Completion (Actual)
October 12, 2023
Study Registration Dates
First Submitted
June 11, 2018
First Submitted That Met QC Criteria
August 7, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Estimated)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 9, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2018-0018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on OCT-guided PCI
-
Odense University HospitalActive, not recruitingMyocardial Infarction | Coronary Artery DiseaseDenmark
-
Catholic University of the Sacred HeartUnknownIschemic Heart DiseaseItaly
-
University Hospital Inselspital, BerneTerminated
-
Aarhus University Hospital SkejbyAbbottActive, not recruitingIschemic Heart Disease | Ischaemic Heart DiseaseDenmark, United Kingdom, Sweden, Finland, Germany, Belgium, Norway, Poland, Netherlands, Estonia, Ireland, Italy, Latvia
-
Careggi HospitalCompletedCoronary Artery | Stent Thrombosis | Platelet | ThrombusItaly
-
Assiut UniversityWakayama Medical UniversityCompleted
-
Harbin Medical UniversityNot yet recruitingIntravascular Imaging and Microvascular Obstruction
-
Chonnam National University HospitalAbbott Medical DevicesRecruitingCoronary Artery Disease | Angina PectorisKorea, Republic of
-
Abbott Medical DevicesAbbottCompletedCoronary Artery Disease | Atherosclerosis | Coronary Stenosis | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial InfarctionUnited States, Spain, Australia, United Kingdom, Canada, New Zealand, Denmark, Switzerland, Germany, Netherlands, India, Japan, Italy, Belgium, France, Hong Kong, Portugal, Singapore, Sweden, Taiwan
-
Abbott Medical DevicesCardiovascular Research Foundation, New YorkCompletedCoronary Artery DiseaseUnited States, Spain, Japan, United Kingdom, Germany, Belgium, Italy, Netherlands