Angina
Conditions
Keywords
stable and unstable angina, bioresorbable vascular scaffold, BVS, PCI
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.
Interventions
DEVICEBioresorbable vascular scaffold (BVS) implantation
Sponsors
KCRI
International Foundation for Development of Medical Science and Education Healthy Heart
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| TVF (Target Vessel Failure) | in 12 month follow-up | — |
| Any revascularization | in 12 month follow-up | Numbers of any revascularization per patient. |
| Stent thrombosis (possible and probable) | in 12 month follow-up | — |
| Periprocedural MI (Myocardial Infarction) (yes/no) | periprocedural | — |
| Angina assessment questionnaire | 12 month follow-up | — |
Countries
Russia
Outcome results
None listed