Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE

Not Applicable

Completed

• Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Atherosclerosis; Coronary Artery Stenosis

• Registration Number: NCT02681016
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-14
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 610

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/mm3.
• 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)
• Anamnesis of previous coronary angioplasty/stenting or CABG
• NYHA class (dyspnoea) IV or hospitalization during last year due to Chronic cardiac failure as a primary diagnosis.
• Pregnancy
• Coronary pathology requiring CABG or staged scheduled coronary angioplasty/stenting except cases of unscheduled staged coronary angioplasty/stenting within 4 weeks after primary procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Target lesion failure	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 Outcome Measures

Name	Time	Method
1 year major adverse cardiac and cerebrovascular events (MACCE)	during 1 year after procedure	1 year major adverse cardiac and cerebrovascular events (MACCE) including: All-cause mortality, Myocardial infarction, Stroke, Stent thrombosis, Clinically indicated Target lesion revascularization, Any target lesion revascularization, Any target vessel revascularization.

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation