Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
NCT ID: NCT02707783
Last Updated: 2018-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1602 participants
OBSERVATIONAL
2015-11-30
2018-07-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bioresorbable vascular scaffold (BVS) implantation
Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation
Bioresorbable vascular scaffold (BVS) implantation
Interventions
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Bioresorbable vascular scaffold (BVS) implantation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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KCRI
OTHER
International Foundation for Development of Medical Science and Education Healthy Heart
OTHER
Responsible Party
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Principal Investigators
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Piotr Musiałek, MD DPhil
Role: STUDY_CHAIR
John Paul II Hospital in Krakow, Poland
Locations
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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
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, , Russia
Tyumen Cardiology Center
Tyumen, , Russia
Countries
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Other Identifiers
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FEAST.RU
Identifier Type: -
Identifier Source: org_study_id