Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE

Study Overview
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Brief Summary
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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)

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

Conditions
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Ischemic Heart Disease, Coronary Atherosclerosis, Coronary Artery Disease, Coronary Artery Stenosis

Intervention / Treatment
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* Device: DES Calypso
* Device: DES Xience Prime
* Procedure: Coronary angioplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sirolimus-eluting stent Calypso<br>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. | Device: DES Calypso<br>* A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.<br>Procedure: Coronary angioplasty<br> <br> |
| Active Comparator: Everolimus-eluting stent Xience Prime<br>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. | Device: DES Xience Prime<br>* A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.<br>Procedure: Coronary angioplasty<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Primary outcome is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. | during 1 year after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year major adverse cardiac and cerebrovascular events (MACCE) | 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. | during 1 year after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calypso, Xience, Coronary stenosis, Drug-eluting stent, Coronary angioplasty with stenting, Ischemic Heart Disease