Sirolimus-eluting Stent CALYPSO vs Everolimus-eluting Stent XIENCE (PATRIOT)

Meshalkin Research Institute of Pathology of Circulation

Status: Completed

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

Treatments: Device: DES "Calypso"; Device: DES "Xience Prime"; Procedure: Coronary angioplasty

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02681016

PAT1.0

Details and patient eligibility

About

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)

Enrollment: 610 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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610 participants in 2 patient groups

Sirolimus-eluting stent "Calypso"

Experimental group

Description:

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.

Treatment:

Procedure: Coronary angioplasty

Device: DES "Calypso"

Everolimus-eluting stent "Xience Prime"

Active Comparator group

Description:

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.

Treatment:

Procedure: Coronary angioplasty

Device: DES "Xience Prime"