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Trial record 1 of 2 for:    talent supraflex stent
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Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02870140
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Sahajanand Medical Technologies Pvt. Ltd.
Information provided by (Responsible Party):
ECRI bv

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Stenosis Device: SUPRAFLEX Device: XIENCE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : September 20, 2018
Estimated Study Completion Date : July 3, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
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.
Device: SUPRAFLEX
Percutaneous Coronary Intervention

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.
Device: XIENCE
Percutaneous Coronary Intervention




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI) [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]
  6. 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 ]
  7. Stent thrombosis rates according to ARC classification [ Time Frame: 30 days, 6 months, 1 year, 2 years and 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870140


Locations
Show Show 23 study locations
Sponsors and Collaborators
ECRI bv
Sahajanand Medical Technologies Pvt. Ltd.
Investigators
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Study Chair: P. W. Serruys, Prof. MD. International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom
Study Chair: U. Kaul, Prof. MD. Fortis Escorts Heart Institute & Research Centre, New Delhi, India
Principal Investigator: R. de Winter, Prof. MD. Academisch Medisch Centrum, Amsterdam, The Netherlands
Principal Investigator: A. Zaman, MD. Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom
Study Director: Gerrit-Anne van Es, PhD ECRI-Trials B.V.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ECRI bv
ClinicalTrials.gov Identifier: NCT02870140    
Other Study ID Numbers: ECRI-007
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

The research data will be entered on separate forms and stored under a code number, according to prevailing legal requirements. No names or other personal data will be stored. Only the study doctor will hold the information to link the code to the patients. The encoded data will be processed, analysed and reported by the research employees of this study, who have an obligation of secrecy.

Representatives of the sponsor or members of the Ethics Committee (EC) and regulatory authorities within Europe can have access to the medical files in order to inspect the correctness of the research data. Data may be provided to representatives and affiliates of the industries supporting the study: Sahajanand Medical Technologies.It is possible that the results of this study are presented or published in medical journals; this will always be without mention of the identity of the patients.

Keywords provided by ECRI bv:
CAD
ACS
All comers
PCI
Additional relevant MeSH terms:
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Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents