Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent

Overview

The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.

Full Title of Study: “A Prospective Multicenter Randomized Post Market All-comer Trial to Assess the Safety and Effectiveness of the SUPRAFLEX Sirolimus-eluting Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: September 20, 2018

Detailed Description

This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in a "Real world, all comers" patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). The objective is to compare the SUPRAFLEX SES with the XIENCE EES with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population.

All patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. The 30 day and 12 month will be a clinic visit. All patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.

Interventions

  • Device: SUPRAFLEX
    • Percutaneous Coronary Intervention
  • Device: XIENCE
    • Percutaneous Coronary Intervention

Arms, Groups and Cohorts

  • Experimental: SUPRAFLEX
    • Percutaneous Coronary Intervention with the SUPRAFLEX Sirolimus Eluting Bioabsorbable Polymer Coronary Stent System. It is a balloon expandable sirolimus eluting stent with an bioabsorbable polymer coating.
  • Active Comparator: XIENCE
    • Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.

Clinical Trial Outcome Measures

Primary Measures

  • Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group
    • Time Frame: 12 months post-procedure
    • TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.

Secondary Measures

  • Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
  • Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
  • TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
  • Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
  • Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
  • Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years
  • Stent thrombosis rates according to ARC classification
    • Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years

Participating in This Clinical Trial

Inclusion Criteria

All comers" patients:

  • Male or female patients 18 years or older;
  • Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation.
  • The vessel should have a reference vessel diameter ranging from ≥2.25 mm to ≤4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria.
  • The patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Patient is willing to comply with all protocol-required evaluations.

Exclusion Criteria

  • Known pregnancy or breastfeeding at time of randomization;
  • Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor;
  • Any PCI treatment within 6 months (<6 months) prior to the index procedure.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • The patient is unwilling/ not able to return for outpatient clinic at 12 months follow-up.
  • Currently participating in another trial and not yet at its primary endpoint.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • ECRI bv
  • Collaborator
    • Sahajanand Medical Technologies Pvt. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • P. W. Serruys, Prof. MD., Study Chair, International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom
    • U. Kaul, Prof. MD., Study Chair, Fortis Escorts Heart Institute & Research Centre, New Delhi, India
    • R. de Winter, Prof. MD., Principal Investigator, Academisch Medisch Centrum, Amsterdam, The Netherlands
    • A. Zaman, MD., Principal Investigator, Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom
    • Gerrit-Anne van Es, PhD, Study Director, ECRI-Trials B.V.

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