Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
- Conditions
- Angina
- Interventions
- Device: Bioresorbable vascular scaffold (BVS) implantation
- Registration Number
- NCT02707783
- Lead Sponsor
- International Foundation for Development of Medical Science and Education Healthy Heart
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1602
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Bioresorbable vascular scaffold (BVS) implantation Bioresorbable vascular scaffold (BVS) implantation Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation
- Primary Outcome Measures
Name Time Method Any revascularization in 12 month follow-up Numbers of any revascularization per patient.
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: no-flow (yes/no) periprocedural Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no) periprocedural Periprocedural MI (Myocardial Infarction) (yes/no) periprocedural Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (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: slow-flow (yes/no) periprocedural Major Adverse Cardiovascular Events in 12 month follow up Angina assessment questionnaire 12 month follow-up Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no) periprocedural TVF (Target Vessel Failure) in 12 month follow-up Stent thrombosis (possible and probable) in 12 month follow-up Acute gain (mm) periprocedural
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
Federal Center for Cardiovascular Surgery
🇷🇺Chelyabinsk, Av. Hero Of Russia 2 Rodionov E.N., Russian Federation
Federal Cardiovascular Center
🇷🇺Perm, Russian Federation
Clinical Hospital No 1 of Department of Presidents Affairs
🇷🇺Moscow, Russian Federation
Regional Clinical Hospital n.a. S.V.
🇷🇺Krasnodar, Ochapovskogo, Russian Federation
Regional Hospital
🇷🇺Magadan, Nagaevskaya 40, Russian Federation
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
🇷🇺Kemerovo, Russian Federation
President's Hospital with Policlinic
🇷🇺Moscow, Russian Federation
Regional Clinical Hospital
🇷🇺Krasnoyarsk, Russian Federation
Central Railway Hospital 2
🇷🇺Moscow, Russian Federation
CELT Hospital
🇷🇺Moscow, Russian Federation
City Clinical Hospital named S.S.Yudina Department of Health of the City of Moscow
🇷🇺Moscow, Russian Federation
Tyumen Cardiology Center
🇷🇺Tyumen, Russian Federation