Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
FEASTRU
1 other identifier
observational
1,602
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2015
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 18, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedDecember 13, 2018
August 1, 2018
1.6 years
February 18, 2016
December 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
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
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
Study Arms (1)
Bioresorbable vascular scaffold (BVS) implantation
Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation
Interventions
Eligibility Criteria
Patients with stable and unstable angina qualified for revascularization (PCI or CABG) after coronary angiography.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Federal Center for Cardiovascular Surgery
Chelyabinsk, Av. Hero of Russia 2 Rodionov E.N., 454003, Russia
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Piotr Musiałek, MD DPhil
John Paul II Hospital in Krakow, Poland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2016
First Posted
March 14, 2016
Study Start
November 1, 2015
Primary Completion
June 1, 2017
Study Completion
July 1, 2018
Last Updated
December 13, 2018
Record last verified: 2018-08