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

International Foundation for Development of Medical Science and Education Healthy Heart

Status: Completed

Conditions: Angina

Treatments: Device: Bioresorbable vascular scaffold (BVS) implantation

Study type: Observational

Funder types: Other

Identifiers

NCT02707783

FEAST.RU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,602 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,602 participants in 1 patient group

Bioresorbable vascular scaffold (BVS) implantation

Description:

Patients with un/stable angina that require coronary revascularization undergoing the BVS implantation

Treatment:

Device: Bioresorbable vascular scaffold (BVS) implantation