Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds

Study Overview
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Brief Summary
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Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain, restore physiological vasomotion, and avoid late adverse events including restenosis and scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several reports have raised concerns regarding the scaffold thrombosis highlighting the importance of technical considerations regarding lesion preparation and scaffold expansion. OCT offers the opportunity to plan the procedure and optimize the implantation of BVS. The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as indicated by OCT).

Official Title
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Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds

Conditions
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Coronary Occlusion

Intervention / Treatment
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* Other: OCT-guided PCI
* Other: Angiography-guided PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. Patient provides signed written informed consent before any study-specific procedure. De novo native coronary artery disease with lesions that have a distal and proximal reference vessel diameter in the range between 2.25mm and 3.8mm. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated at baseline with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel. Full revascularization of all lesions should be achievable (staged PCI not recommended) Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI). Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia. Exclusion Criteria: Subjects with left main lesion. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left). Subjects with restenosis or stent thrombosis in the target vessel. Severely calcified lesions requiring rotablation. Bifurcation with sidebranch >2.5mm or any sidebranch that possibly requires treatment with angulation >70° Severe angulation (>90°) or excessive tortuosity (>two 45° angles) Known renal insufficiency (serum creatinine clearance <45ml/min or receiving dialysis). Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease. Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy Life expectancy less than 1 year. Indication for oral anticoagulation Known allergy against protocol-required medications including ASA, prasugrel, ticagrelor, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated) History of bleeding diathesis or known coagulopathy. Planned surgery within the next 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCT-guided PCI<br>OCT before and after Stent implantation | Other: OCT-guided PCI<br>* Patients assigned to the OCT-guided PCI strategy will undergo OCT prior to PCI to determine vessel and lesion dimensions and treatment strategy. OCT will be repeated at the end of the procedure and corrective PCI will aim to optimize the PCI result according to pre-specified criteria in terms of minimal lumen area, scaffold expansion, apposition, residual dissections or intra-scaffold thrombus formation<br>|
| Active Comparator: Angiography-guided PCI<br>OCT after Stent implantation | Other: Angiography-guided PCI<br>* Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal in-scaffold lumen area (mm2) as assessed by OCT | The lumen area is assessed by OCT | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Adverse events are defined as scaffold underexpansions, significant strut malappositions or uncovered struts, expansion asymmetries, any intrascaffold tissue, edge dissections, or restenoses (as assessed by OCT) | 6 months | 
| OCT imaging endpoints | Scaffold underexpansion, significant strut malapposition or uncovered struts, expansion asymmetry, any intrascaffold tissue, edge dissection, or restenosis. (as assessed by OCT) | 6 months | 
| Additional OCT imaging endpoints | Significant malapposed scaffold struts, % Malapposed scaffold struts, % Uncovered scaffold struts, % Incomplete scaffold apposition area, mm2 Incomplete scaffold apposition distance, mm Neointimal thickness, µm Neointimal area, mm2 Volume obstruction, % | 6 months | 
| OCT imaging endpoints | Minimal in-scaffold lumen area, mm Scaffold expansion, % No of patients with scaffold expansion <80% % lesions with significant malapposition % malapposed struts | end of procedure | 
| angiographic endpoints | acute lumen gain in-scaffold minimal lumen diameter in-segment minimal lumen diameter in-scaffold % diameter stenosis in-segment % diameter stenosis | end of procedure | 
| angiographic endpoints | In-scaffold late lumen loss, mm In-segment late lumen loss, mm In-scaffold % diameter stenosis In-segment % diameter stenosis Binary restenosis, % Percent diameter stenosis, % | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Stents