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

M

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

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"

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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