Angina Clinical Trial
Official title:
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
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.
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.
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