Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE
Not Applicable
Completed
- Conditions
- Ischemic Heart DiseaseCoronary Artery DiseaseCoronary AtherosclerosisCoronary Artery Stenosis
- Interventions
- Device: DES "Xience Prime"Device: DES "Calypso"Procedure: Coronary angioplasty
- 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
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
- Arm && Interventions
Group Intervention Description Sirolimus-eluting stent "Calypso" Coronary angioplasty Commercially approved coronary stent system "Calypso" (Angioline, Russia) Coating - Sirolimus(rapamicine) Stent diameters: 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 4.5 mm. Stent lengths: 8, 13, 15, 18, 23, 28, 33, 38 mm. Everolimus-eluting stent "Xience Prime" DES "Xience Prime" Commercially approved XIENCE PRIME, (Abbott Vascular, USA) Coating - Everolimus with concentration Stent diameters: 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm. Stent lengths: 8, 12, 15, 18, 23, 28, 33, 38 mm. Sirolimus-eluting stent "Calypso" DES "Calypso" Commercially approved coronary stent system "Calypso" (Angioline, Russia) Coating - Sirolimus(rapamicine) Stent diameters: 2.0, 2.25, 2.5, 2.75, 3.0, 3.5, 4.0, 4.5 mm. Stent lengths: 8, 13, 15, 18, 23, 28, 33, 38 mm. Everolimus-eluting stent "Xience Prime" Coronary angioplasty Commercially approved XIENCE PRIME, (Abbott Vascular, USA) Coating - Everolimus with concentration Stent diameters: 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm. Stent lengths: 8, 12, 15, 18, 23, 28, 33, 38 mm.
- 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