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

NCT02870140 | Completed DMC

• 1 other identifier: ECRI-007
• Study Type: interventional
• Target: 1,435
• Locations: 7 countries
• Sites: 23

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.

Conditions

Coronary Stenosis

Keywords

CAD; ACS; All comers; PCI

Outcome Measures

Primary Outcomes (1)

• Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group

  TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization.

  12 months post-procedure

Secondary Outcomes (7)

• Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization

  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

  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)

  30 days, 6 months, 1 year, 2 years and 3 years

• Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)

  30 days, 6 months, 1 year, 2 years and 3 years

• Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)

  30 days, 6 months, 1 year, 2 years and 3 years

Study Arms (2)

SUPRAFLEX

EXPERIMENTAL

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

XIENCE

ACTIVE COMPARATOR

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

Interventions

SUPRAFLEX DEVICE

Percutaneous Coronary Intervention

SUPRAFLEX

XIENCE DEVICE

Percutaneous Coronary Intervention

XIENCE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ECRI bv: lead
• Sahajanand Medical Technologies Limited: collaborator

Study Sites (23)

Research Centre BG-004

Plovdiv, Bulgaria

Location

Research Centre BG-001

Sofia, Bulgaria

Location

Research Centre HU-002

Budapest, Hungary

Location

Research Centre HU-001

Szeged, Hungary

Location

Research Centre IT-001

Milan, Italy

Location

Research Centre NL-007

Amsterdam, Netherlands

Location

Research Centre NL-008

Breda, Netherlands

Location

Research Centre NL-009

Eindhoven, Netherlands

Location

Research Centre NL-002

Leeuwarden, Netherlands

Location

Research Centre NL-003

Rotterdam, Netherlands

Location

Research Centre PL-002

Chrzanów, Poland

Location

Research Centre PL-005

Kędzierzyn-Koźle, Poland

Location

Research Centre NL-009

Warsaw, Poland

Location

Research Centre ES-003

Barcelona, Spain

Location

Research Centre ES-005

Barcelona, Spain

Location

Research Centre ES-012

Madrid, Spain

Location

Research Centre ES-018

Vigo, Spain

Location

Research Centre GB-021

Belfast, United Kingdom

Location

Research Centre GB-002

Cardiff, United Kingdom

Location

Research Centre GB-010

Cottingham, United Kingdom

Location

Research Centre GB-022

London, United Kingdom

Location

Research Centre GB-013

Newcastle upon Tyne, United Kingdom

Location

Research Centre GB-012

Stevenage, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 35285804 DERIVED

• 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.

  PMID: 34666500 DERIVED

• 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.

  PMID: 30827782 DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• 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

  STUDY CHAIR

• R. de Winter, Prof. MD.

  Academisch Medisch Centrum, Amsterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• A. Zaman, MD.

  Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom

  PRINCIPAL INVESTIGATOR

• Ernest Spitzer, MD.

  ECRI-Trials B.V. (E.Spitzer@ECRI-Trials.com)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 17, 2016
• Study Start: October 21, 2016
• Primary Completion: September 20, 2018
• Study Completion: August 26, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

BU (2); NL (5); ES (4); HU (2); IT (1); PL (3); GB (6)