Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina (FEASTRU)

December 12, 2018 updated by: International Foundation for Development of Medical Science and Education Healthy Heart

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 (Actual)

1602

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Kaliningrad, Russian Federation, 238 312
        • Federal Cardiovascular Center
      • Kemerovo, Russian Federation, 650002
        • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
      • Krasnoyarsk, Russian Federation
        • Regional Clinical Hospital
      • Moscow, Russian Federation, 121352
        • Clinical Hospital No 1 of Department of Presidents Affairs
      • Moscow, Russian Federation, 121359
        • President's Hospital with Policlinic
      • Moscow, Russian Federation, 129128
        • Central Railway Hospital 2
      • Moscow, Russian Federation
        • CELT Hospital
      • Moscow, Russian Federation
        • City Clinical Hospital named S.S.Yudina Department of Health of the City of Moscow
      • Perm, Russian Federation, 614 013
        • Federal Cardiovascular Center
      • Tyumen, Russian Federation
        • Tyumen Cardiology Center
    • Av. Hero Of Russia 2 Rodionov E.N.
      • Chelyabinsk, Av. Hero Of Russia 2 Rodionov E.N., Russian Federation, 454003
        • Federal Center for Cardiovascular Surgery
    • Karaulnaya 45
      • Krasnoyarsk, Karaulnaya 45, Russian Federation
        • Federal Cardiovascular Center
    • Nagaevskaya 40
      • Magadan, Nagaevskaya 40, Russian Federation, 685 000
        • Regional Hospital
    • Ochapovskogo
      • Krasnodar, Ochapovskogo, Russian Federation, 350 086
        • Regional Clinical Hospital n.a. S.V.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with stable and unstable angina qualified for revascularization (PCI or CABG) after coronary angiography.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bioresorbable vascular scaffold (BVS) implantation
Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation
Device: Bioresorbable vascular scaffold (BVS) implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)
Time Frame: periprocedural
periprocedural
Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)
Time Frame: periprocedural
periprocedural
Acute gain (mm)
Time Frame: periprocedural
periprocedural
Major Adverse Cardiovascular Events
Time Frame: From hospital discharge till 12 months follow up
From hospital discharge till 12 months follow up
Major Adverse Cardiovascular Events
Time Frame: in 12 month follow up
in 12 month follow up
TVF (Target Vessel Failure)
Time Frame: in 12 month follow-up
in 12 month follow-up
Any revascularization
Time Frame: in 12 month follow-up
Numbers of any revascularization per patient.
in 12 month follow-up
Stent thrombosis (possible and probable)
Time Frame: in 12 month follow-up
in 12 month follow-up
Periprocedural MI (Myocardial Infarction) (yes/no)
Time Frame: periprocedural
periprocedural
Angina assessment questionnaire
Time Frame: 12 month follow-up
12 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Foundation for Development of Medical Science and Education Healthy Heart

Collaborators

KCRI

Investigators

  • Study Chair: Piotr Musiałek, MD DPhil, John Paul II Hospital in Krakow, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

December 13, 2018

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEAST.RU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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