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

NCT ID: NCT02870140

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1435 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-21

Study Completion Date

2020-08-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Stenosis

Keywords

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CAD ACS All comers PCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

SUPRAFLEX

Intervention Type DEVICE

Percutaneous Coronary Intervention

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.

Group Type ACTIVE_COMPARATOR

XIENCE

Intervention Type DEVICE

Percutaneous Coronary Intervention

Interventions

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SUPRAFLEX

Percutaneous Coronary Intervention

Intervention Type DEVICE

XIENCE

Percutaneous Coronary Intervention

Intervention Type DEVICE

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahajanand Medical Technologies Limited

INDUSTRY

Sponsor Role collaborator

ECRI bv

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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P. W. Serruys, Prof. MD.

Role: STUDY_CHAIR

International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom

U. Kaul, Prof. MD.

Role: STUDY_CHAIR

Fortis Escorts Heart Institute & Research Centre, New Delhi, India

R. de Winter, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

Academisch Medisch Centrum, Amsterdam, The Netherlands

A. Zaman, MD.

Role: PRINCIPAL_INVESTIGATOR

Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom

Ernest Spitzer, MD.

Role: STUDY_DIRECTOR

ECRI-Trials B.V. ([email protected])

Locations

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Research Centre BG-004

Plovdiv, , Bulgaria

Site Status

Research Centre BG-001

Sofia, , Bulgaria

Site Status

Research Centre HU-002

Budapest, , Hungary

Site Status

Research Centre HU-001

Szeged, , Hungary

Site Status

Research Centre IT-001

Milan, , Italy

Site Status

Research Centre NL-007

Amsterdam, , Netherlands

Site Status

Research Centre NL-008

Breda, , Netherlands

Site Status

Research Centre NL-009

Eindhoven, , Netherlands

Site Status

Research Centre NL-002

Leeuwarden, , Netherlands

Site Status

Research Centre NL-003

Rotterdam, , Netherlands

Site Status

Research Centre PL-002

Chrzanów, , Poland

Site Status

Research Centre PL-005

Kędzierzyn-Koźle, , Poland

Site Status

Research Centre NL-009

Warsaw, , Poland

Site Status

Research Centre ES-003

Barcelona, , Spain

Site Status

Research Centre ES-005

Barcelona, , Spain

Site Status

Research Centre ES-012

Madrid, , Spain

Site Status

Research Centre ES-018

Vigo, , Spain

Site Status

Research Centre GB-021

Belfast, , United Kingdom

Site Status

Research Centre GB-002

Cardiff, , United Kingdom

Site Status

Research Centre GB-010

Cottingham, , United Kingdom

Site Status

Research Centre GB-022

London, , United Kingdom

Site Status

Research Centre GB-013

Newcastle upon Tyne, , United Kingdom

Site Status

Research Centre GB-012

Stevenage, , United Kingdom

Site Status

Countries

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Bulgaria Hungary Italy Netherlands Poland Spain United Kingdom

References

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de Winter RJ, Zaman A, Hara H, Gao C, Ono M, Garg S, Smits PC, Tonino PAL, Hofma SH, Moreno R, Choudhury A, Petrov I, Cequier A, Colombo A, Kaul U, Onuma Y, Serruys PW. Sirolimus-eluting stents with ultrathin struts versus everolimus-eluting stents for patients undergoing percutaneous coronary intervention: final three-year results of the TALENT trial. EuroIntervention. 2022 Aug 19;18(6):492-502. doi: 10.4244/EIJ-D-21-00766.

Reference Type DERIVED
PMID: 35285804 (View on PubMed)

Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.

Reference Type DERIVED
PMID: 34666500 (View on PubMed)

Zaman A, de Winter RJ, Kogame N, Chang CC, Modolo R, Spitzer E, Tonino P, Hofma S, Zurakowski A, Smits PC, Prokopczuk J, Moreno R, Choudhury A, Petrov I, Cequier A, Kukreja N, Hoye A, Iniguez A, Ungi I, Serra A, Gil RJ, Walsh S, Tonev G, Mathur A, Merkely B, Colombo A, Ijsselmuiden S, Soliman O, Kaul U, Onuma Y, Serruys PW; TALENT trial investigators. Safety and efficacy of a sirolimus-eluting coronary stent with ultra-thin strut for treatment of atherosclerotic lesions (TALENT): a prospective multicentre randomised controlled trial. Lancet. 2019 Mar 9;393(10175):987-997. doi: 10.1016/S0140-6736(18)32467-X. Epub 2019 Feb 28.

Reference Type DERIVED
PMID: 30827782 (View on PubMed)

Other Identifiers

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ECRI-007

Identifier Type: -

Identifier Source: org_study_id