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.
Study Type
OBSERVATIONAL
Enrollment
1,602
Federal Center for Cardiovascular Surgery
Chelyabinsk, Av. Hero of Russia 2 Rodionov E.N., Russia
Federal Cardiovascular Center
Krasnoyarsk, Karaulnaya 45, Russia
Regional Hospital
Magadan, Nagaevskaya 40, Russia
Regional Clinical Hospital n.a. S.V.
Krasnodar, Ochapovskogo, Russia
Federal Cardiovascular Center
Kaliningrad, Russia
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, Russia
Regional Clinical Hospital
Krasnoyarsk, Russia
Clinical Hospital No 1 of Department of Presidents Affairs
Moscow, Russia
President's Hospital with Policlinic
Moscow, Russia
Central Railway Hospital 2
Moscow, Russia
...and 4 more locations
Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)
Time frame: periprocedural
Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)
Time frame: periprocedural
Acute gain (mm)
Time frame: periprocedural
Major Adverse Cardiovascular Events
Time frame: From hospital discharge till 12 months follow up
Major Adverse Cardiovascular Events
Time frame: in 12 month follow up
TVF (Target Vessel Failure)
Time frame: in 12 month follow-up
Any revascularization
Numbers of any revascularization per patient.
Time frame: in 12 month follow-up
Stent thrombosis (possible and probable)
Time frame: in 12 month follow-up
Periprocedural MI (Myocardial Infarction) (yes/no)
Time frame: periprocedural
Angina assessment questionnaire
Time frame: 12 month follow-up
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