Impact of Real-time Angiographic Co-registered OCT on PCI Results - the OPTICO-integration II Study (Integration-II)

Impact of Real-time Angiographic Co-registered OCT on PCI Results - the Randomized OPTICO-integration II Study

Intracoronary optical coherence tomography (OCT) imaging allows for high-resolution characterization of coronary lesions. Difficulties in matching cross-sectional OCT-images with angiographic lesion localization, however, may limit its clinical utilization. The investigators sought to prospectively assess the impact of a novel system of real-time OCT-coregistration with angiography (ACR) compared to OCT alone and to the clinical standard proceeding (angiographic guided-PCI) all used for coronary lesion evaluation before percutaneous coronary interventions (PCI). The investigators hypothesize that the use of ACR will lead to less incidence of insufficient covered coronary lesions (geographical mismatch) and/or a less rate of edge dissections after PCI (combined primary study endpoint)

Study Overview

• Status: Completed
• Conditions: Ischaemic Heart Disease
• Intervention / Treatment: Procedure: Angio-PCI; Procedure: OCT-PCI; Procedure: ACR-PCI

Detailed Description

In this randomized blinded pilot-study the effect of pre-PCI planning by angiographic-co-registered OCT (ACR) compared to OCT or angiographic evaluation alone with respect to the entire result after PCI will be investigated. A special focus (primary endpoint) will be on the incidence of geographical mismatch (GM) and/or major edge dissections. Eligible patients will be randomized in three groups.

Group 1 Pre-PCI-OCT: Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings.

Group 2: Pre-PCI-ACR: Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings.

Group 3:OCT-Blinded/Angiographic guided PCI: Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care).

For outcome analysis all study groups underwent post-PCI-OCT imaging as soon as investigators assume angiographic justiciable PCI-results (TIMI III, no residual stenosis > 50%; no angiographic definable or suspicious edge dissections, angiographic acceptable stent expansion without evidence for malapposition). OCT imaging analysis will be performed within a OCT core-lab by two investigators blinded for the randomization group.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient with indication for coronary angiography for angina (stable or unstable), silent ischemia (a visually estimated target lesion diameter stenosis of ≥70%, a positive invasive or non-invasive test must be present), or NSTE-ACS
• male or non pregnant female patient
• Signed written informed consent

Exclusion Criteria:

• Known neoplasia on treatment / without a curative therapeutic approach
• Presence of one or more co-morbidities which reduces life expectancy to less than 24 months
• Estimated creatinine clearance <40 ml/min
• Cardiogenic shock
• Hemodynamic instability because of arrhythmia
• Known left ventricular ejection fraction (LVEF) <30%.
• Therapy requiring psychiatric disorder
• Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint.
• Women who are pregnant or breastfeeding
• Refusal of study participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Blinded-group; Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators only based on angiographic lesion evaluation (standard care)	Procedure: Angio-PCI; PCI only with angiography and without OCT findings
Active Comparator: OCT-group; Patients underwent OCT-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on OCT findings	Procedure: OCT-PCI; PCI with OCT-measurements but no transfer of landingzone-markers to angiography
Experimental: ACR-group; Patients underwent ACR-imaging before PCI. Lesion assessment, selection of PCI landing zone as well as stent selection will be performed by investigators based on ACR-findings	Procedure: ACR-PCI; PCI with OCT-measurements and transfer of landingzone-markers to angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of a combined endpoint based on "major edge dissections" (I) AND/OR "geographical mismatch" (II) [%]	Analysis of primary endpoint will be assessed by evaluation of proximal and/or distal stent end. I) Major edge dissection (MED): Major: ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length II) Geographical mismatch (GM): Untreated plaque with a minimal lumen area <4,5mm2 within 5mm of the reference segment. In the postPCI-OCT analysis it is considered as no geographical mismatch, if: the segment of the lesion is fully covered AND; the stent protrudes maximal 5mm beyond the predetermined landing zone. If one of these criteria is not fulfilled, it is considered as geographical mismatch	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of "major edge dissections" [%]	All secondary endpoints of OCT will be assessed by evaluation of proximal and/or distal stent end/segment.	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of "all edge dissections" (major (I) and minor (II)) [%]	(I) ≥60 degrees of the circumference of the vessel at site of dissection and/or ≥3 mm in length (II) Any visible edge dissection <60 degrees of the circumference of the vessel and < 3 mm in length	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of "geographical mismatch" [%]	see primary endpoint	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Stent expansion [%]	Defined by the MSA achieved relative to the proximal or distal reference segments. The stent length is divided into 2 equal segments (proximal and distal), and the MSA is determined in each segment.; Optimal stent expansion: The MSA of the segment is ≥95% of the related reference lumen area; Acceptable stent expansion: The MSA of the segment is ≥90% and <95% of the related reference lumen area; Unacceptable stent expansion: The MSA of the segment is <90% of the related lumen area	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Inacceptable stent expansion [%]	see outcome 5	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Incidence of "malapposition" [%]	Incompletely apposed stent struts in at least 5 consecutive OCT-frames (defined as stent struts clearly separated from the vessel wall (lumen border/plaque border) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch). Malapposition will be further classified as: A) Major: If associated with stent underexpansion (unacceptable stent expansion as defined above) B) Minor: If not associated with significant underexpansion (optimal or acceptable stent expansion as defined above) C) Major and minor	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Distance between target and actual lesion coverage [mm]	Defined as the distance between target landing zone and actual landing zone of stent location (proximal and distal end). Therefore, the lesion is divided in two equal halves, so that every segment (proximal and distal) can be analyzed for itself.	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Minimal Stent Area (MSA) of target lesion [%]	Minimal lumen area covered by stent.	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Acute Luminal Gain of target lesion [mm]	Gain of Minimal Lumen Diameter (MLD) between prePCI- and postPCI-OCT	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Procedure time [min]	Time from reaching the ostium with the guide catheter until pullback of the last one.	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total fluoroscopy time [min]	Total time required for diagnostic angiography and PCI.	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total contrast volume [ml]	Total amount of contrast used for entire intervention (including OCT-pullbacks)	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total stent length [mm]	Addition of each stent length which were used for target lesion	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Total number of stents	Number of stents which were used for target lesion	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Maximal stent diameter [mm]	Maximal stent diameter used for target lesion	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Complications associated with OCT-examination [%]	Complications between advancing and pullback of OCT catheter	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
Complications during hospitalization [%]	Defined as: new ACS; stent thrombosis of study culprit lesion; new unplaned coronary angiography; new revascularization (PCI/CABG); apoplex/TIA; pacemaker implantation; anaphylactic shock; contrast-induced nephropathy; bleeding; death	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours
DOCE within target lesion [%]	Device-oriented composite endpoint within the target lesion. Defined as cardiovascular death, myocardial infarction OR target-lesion revascularization. This composite endpoint will be checked during a follow up after 1 and 3 months.	Time of PCI Procedure - participants will be followed for the duration of hospital stay, an expected average of 24 hours

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: David M Leistner, PD Dr. med., Managing Senior Physician

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2018
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: August 5, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: OCT; PCI; Stent; Co-Registration; Geographical mismatch; Edge Dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: OPTICO-Integration II

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