NCT02707783

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,602 (actual)
• Sponsor: International Foundation for Development of Medical Science and Education Healthy Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Angina

Interventions

Type	Name	Description
DEVICE	Bioresorbable vascular scaffold (BVS) implantation

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-06-01
• Completion: 2018-07-01
• First posted: 2016-03-14
• Last updated: 2018-12-13

Locations

14 sites across 1 country: Russia