NCT02681016 - Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE | Crick

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

610

Conditions

Ischemic Heart Disease Coronary Atherosclerosis Coronary Artery Disease Coronary Artery Stenosis

Interventions

DES "Calypso"DEVICE

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.

DES "Xience Prime"DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

State Research Institute of CIrculation Pathology

Novosibirsk, Russia

Outcomes

Primary Outcomes

Target lesion failure

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

Time frame: during 1 year after procedure

Secondary Outcomes

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.

Time frame: during 1 year after procedure