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

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

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

Conditions
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Ischaemic Heart Disease

Intervention / Treatment
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* Procedure: Angio-PCI
* Procedure: OCT-PCI
* Procedure: ACR-PCI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blinded-group<br>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<br>* PCI only with angiography and without OCT findings<br>|
| Active Comparator: OCT-group<br>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<br>* PCI with OCT-measurements but no transfer of landingzone-markers to angiography<br>|
| Experimental: ACR-group<br>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<br>* PCI with OCT-measurements and transfer of landingzone-markers to angiography<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Stent, Co-Registration, PCI, Geographical mismatch, Edge Dissection