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| Name | Class |
|---|---|
| KCRI | OTHER |
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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.
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:
The enrollment phase of the registry is not expected to last longer than 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioresorbable vascular scaffold (BVS) implantation | Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioresorbable vascular scaffold (BVS) implantation | Device |
|
| 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 |
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Inclusion Criteria:
Patient characteristics
Exclusion Criteria:
Patient characteristics
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Patients with stable and unstable angina qualified for revascularization (PCI or CABG) after coronary angiography.
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Musiałek, MD DPhil | John Paul II Hospital in Krakow, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Center for Cardiovascular Surgery | Chelyabinsk | Av. Hero of Russia 2 Rodionov E.N. | 454003 | Russia | ||
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| 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 |
| Federal Cardiovascular Center |
| Krasnoyarsk |
| Karaulnaya 45 |
| Russia |
| Regional Hospital | Magadan | Nagaevskaya 40 | 685 000 | Russia |
| Regional Clinical Hospital n.a. S.V. | Krasnodar | Ochapovskogo | 350 086 | Russia |
| Federal Cardiovascular Center | Kaliningrad | 238 312 | Russia |
| Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases | Kemerovo | 650002 | Russia |
| Regional Clinical Hospital | Krasnoyarsk | Russia |
| Clinical Hospital No 1 of Department of Presidents Affairs | Moscow | 121352 | Russia |
| President's Hospital with Policlinic | Moscow | 121359 | Russia |
| Central Railway Hospital 2 | Moscow | 129128 | Russia |
| CELT Hospital | Moscow | Russia |
| City Clinical Hospital named S.S.Yudina Department of Health of the City of Moscow | Moscow | Russia |
| Federal Cardiovascular Center | Perm | 614 013 | Russia |
| Tyumen Cardiology Center | Tyumen | Russia |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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