Prospective rAndomized, Single-blind, multicenTral Control Clinical Trial of Sirolimus-eluting coRonary Stent "Calypso" (Angioline) vs Everolimus-elutIng cOronary stenT "Xience Prime" (Abbott Vascular)

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country610 target enrollmentMarch 2015

ConditionsIschemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemic Heart Disease
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 610
Locations: 1
Primary Endpoint: Target lesion failure
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to evaluate the efficacy and safety of sirolimus-eluting coronary stent "Calypso" (Angioline, Russia) in comparison with everolimus-eluting coronary stent "Xience" (Abbott Vascular, USA)

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

July 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients considered for coronary angioplasty with stenting due to Ischemic heart disease (Stable angina, Unstable angina, non-ST Myocardial Infarction).
•Target vessel lesion in coronary artery with diameter measurements \>2.5 mm \& \< 4.5 mm.
•Signed, documented informed consent prior to admission to the study

Exclusion Criteria

•Age \<18 years or \>75 years
•Renal insufficiency (GFR/MDRD \<30 ml/min)
•Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm
•Known non-adherence to DAPT
•LVEF \<30%
•Known oncology
•Severe cardiac valvular pathology, requiring operative treatment within 1 year
•Anemia (HB\<100 g/l)
•Continuing bleeding
•Acute coronary syndrome (ST-elevation Myocardial infarction)

Outcomes

Primary Outcomes

Target lesion failure

Time Frame: during 1 year after procedure

Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.