Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina

Study Overview
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Brief Summary
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The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population. The hypothesis of this registry study: 1) Complete coronary revascularization with BVS implantation will be feasible to perform in at least 70 percent of patient population with stable and unstable angina qualified for revascularization after coronary angiography, 2) Complete revascularization with BVS is as safe and effective as revascularization with standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published literature comparators in matched populations). Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres. 12 month clinical observation and 5-year clinical follow-up is expected.

Detailed Description
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Study design: Data regarding all consecutive patients qualified for revascularization (PCI Percutaneous Coronary Intervention or CABG Coronary Artery Bypass Grafting) will be collected in this prospective study. Information regarding revascularization strategy will be collected as detailed information concerning PCI procedure. In case of PCI with other than BVS stent implantation (BMS or/and metallic DES) information collected in the study will contain at least: Reason why BVS was not implanted Final result of baseline treatment Acute and long-term outcome of treatment (12 month clinical observation); NB. 5-year clinical follow-up is also expected. The enrollment phase of the registry is not expected to last longer than 12 months.

Official Title
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Feasibility and Outcomes of Complete Coronary Revascularization Using Bioresorbable Vascular Scaffold in All-comer Patients With Stable and Unstable Angina: A Multi-centre Registry in Russian Population

Conditions
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Angina

Intervention / Treatment
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* Device: Bioresorbable vascular scaffold (BVS) implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient characteristics Age > 18 years Able and willing to give informed consent Willing to comply with specified follow-up evaluations Clinical manifestation of coronary artery disease: stable angina or unstable angina Indications for coronary revascularization Exclusion Criteria: Patient characteristics Acute Myocardial infarction Cardiogenic shock Any reason for patient's inability to comply with 12-month double antiplatelet therapy (DAPT) Absolute contraindications to DES or BVS implantation

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Bioresorbable vascular scaffold (BVS) implantation<br>Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation | Device: Bioresorbable vascular scaffold (BVS) implantation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no) |  | periprocedural | 
| Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no) |  | periprocedural | 
| Acute gain (mm) |  | periprocedural | 
| Major Adverse Cardiovascular Events |  | From hospital discharge till 12 months follow up | 
| Major Adverse Cardiovascular Events |  | in 12 month follow up | 
| TVF (Target Vessel Failure) |  | in 12 month follow-up | 
| Any revascularization | Numbers of any revascularization per patient. | in 12 month follow-up | 
| Stent thrombosis (possible and probable) |  | in 12 month follow-up | 
| Periprocedural MI (Myocardial Infarction) (yes/no) |  | periprocedural | 
| Angina assessment questionnaire |  | 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stable and unstable angina, bioresorbable vascular scaffold, BVS, PCI