Skip to main content
OpenTrials
Completed

NCT Number: NCT02707783

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Angina Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal Center for Cardiovascular Surgery, Chelyabinsk, Av. Hero of Russia 2 Rodionov E.N., Russia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bioresorbable vascular scaffold (BVS) implantation

Device

Primary outcomes

  1. Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)

    Time frame: periprocedural

  2. Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)

    Time frame: periprocedural

  3. Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)

    Time frame: periprocedural

  4. Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)

    Time frame: periprocedural

  5. Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)

    Time frame: periprocedural

  6. Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)

    Time frame: periprocedural

  7. Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)

    Time frame: periprocedural

  8. Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)

    Time frame: periprocedural

  9. Acute gain (mm)

    Time frame: periprocedural

  10. Major Adverse Cardiovascular Events

    Time frame: From hospital discharge till 12 months follow up

  11. Major Adverse Cardiovascular Events

    Time frame: in 12 month follow up

  12. TVF (Target Vessel Failure)

    Time frame: in 12 month follow-up

  13. Any revascularization

    Time frame: in 12 month follow-up

    Numbers of any revascularization per patient.

  14. Stent thrombosis (possible and probable)

    Time frame: in 12 month follow-up

  15. Periprocedural MI (Myocardial Infarction) (yes/no)

    Time frame: periprocedural

  16. Angina assessment questionnaire

    Time frame: 12 month follow-up

Sponsors and collaborators

Lead sponsor

International Foundation for Development of Medical Science and Education Healthy Heart

Other

Collaborators

  • KCRI

Registry information

Official study title

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

Acronym: FEASTRU

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 14, 2016
Registry last updated
Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.