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

Angina Clinical Trial

— FEASTRU  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707783
• Other study ID #: FEAST.RU
• Status: Completed
• Start date: November 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: International Foundation for Development of Medical Science and Education Healthy Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1602
• Est. completion date: July 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina
• Angina Pectoris

Intervention

Device:
• Bioresorbable vascular scaffold (BVS) implantation

Locations

Country	Name	City	State
Russian Federation	Federal Center for Cardiovascular Surgery	Chelyabinsk	Av. Hero Of Russia 2 Rodionov E.N.
Russian Federation	Federal Cardiovascular Center	Kaliningrad
Russian Federation	Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases	Kemerovo
Russian Federation	Regional Clinical Hospital n.a. S.V.	Krasnodar	Ochapovskogo
Russian Federation	Federal Cardiovascular Center	Krasnoyarsk	Karaulnaya 45
Russian Federation	Regional Clinical Hospital	Krasnoyarsk
Russian Federation	Regional Hospital	Magadan	Nagaevskaya 40
Russian Federation	CELT Hospital	Moscow
Russian Federation	Central Railway Hospital 2	Moscow
Russian Federation	City Clinical Hospital named S.S.Yudina Department of Health of the City of Moscow	Moscow
Russian Federation	Clinical Hospital No 1 of Department of Presidents Affairs	Moscow
Russian Federation	President's Hospital with Policlinic	Moscow
Russian Federation	Federal Cardiovascular Center	Perm
Russian Federation	Tyumen Cardiology Center	Tyumen

Sponsors (2)

Lead Sponsor	Collaborator
International Foundation for Development of Medical Science and Education Healthy Heart	KCRI

Country where clinical trial is conducted

Russian Federation, 

Outcome

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