Clinical trial NCT02707783: Feasibility and Outcomes of Complete Coronary Revascularization Using BVS in All-comer Patients With Angina
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina
Keywords: stable and unstable angina
bioresorbable vascular scaffold
BVS
PCI
Lead sponsor: International Foundation for Development of Medical Science and Education Healthy Heart
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2016-03-14
Enrollment: 1602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable and unstable angina qualified for revascularization (PCI or CABG) after coronary angiography.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)
timeFrame: periprocedural
measure: Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)
timeFrame: periprocedural
measure: Acute gain (mm)
timeFrame: periprocedural
measure: Major Adverse Cardiovascular Events
timeFrame: From hospital discharge till 12 months follow up
measure: Major Adverse Cardiovascular Events
timeFrame: in 12 month follow up
measure: TVF (Target Vessel Failure)
timeFrame: in 12 month follow-up
measure: Any revascularization
timeFrame: in 12 month follow-up
measure: Stent thrombosis (possible and probable)
timeFrame: in 12 month follow-up
measure: Periprocedural MI (Myocardial Infarction) (yes/no)
timeFrame: periprocedural
measure: Angina assessment questionnaire
timeFrame: 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Federal Center for Cardiovascular Surgery
state: Av. Hero Of Russia 2 Rodionov E.N.
city: Krasnoyarsk
country: Russian Federation
facility: Federal Cardiovascular Center
state: Karaulnaya 45
city: Magadan
country: Russian Federation
facility: Regional Hospital
state: Nagaevskaya 40
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital n.a. S.V.
state: Ochapovskogo
city: Kaliningrad
country: Russian Federation
facility: Federal Cardiovascular Center
city: Kemerovo
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
city: Krasnoyarsk
country: Russian Federation
facility: Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Clinical Hospital No 1 of Department of Presidents Affairs
city: Moscow
country: Russian Federation
facility: President's Hospital with Policlinic
city: Moscow
country: Russian Federation
facility: Central Railway Hospital 2
city: Moscow
country: Russian Federation
facility: CELT Hospital
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named S.S.Yudina Department of Health of the City of Moscow
city: Perm
country: Russian Federation
facility: Federal Cardiovascular Center
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Center
Study officials:
affiliation: John Paul II Hospital in Krakow, Poland
name: Piotr Musiałek, MD DPhil
role: STUDY_CHAIR
References: