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Clinical Trials/NCT02681016
NCT02681016
Completed
Not Applicable

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

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

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.

Secondary Outcomes

  • 1 year major adverse cardiac and cerebrovascular events (MACCE)(during 1 year after procedure)

Study Sites (1)

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