Clinical trial NCT02870140: Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenosis
Keywords: CAD
ACS
All comers
PCI
Lead sponsor: ECRI bv
Sponsor class: INDUSTRY
Collaborators: name: Sahajanand Medical Technologies Limited
First posted: 2016-08-17
Enrollment: 1435
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
measure: Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
measure: TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months)
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
measure: Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular)
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
measure: Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI)
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
measure: Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR.
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
measure: Stent thrombosis rates according to ARC classification
timeFrame: 30 days, 6 months, 1 year, 2 years and 3 years
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Research Centre BG-004
city: Sofia
country: Bulgaria
facility: Research Centre BG-001
city: Budapest
country: Hungary
facility: Research Centre HU-002
city: Szeged
country: Hungary
facility: Research Centre HU-001
city: Milan
country: Italy
facility: Research Centre IT-001
city: Amsterdam
country: Netherlands
facility: Research Centre NL-007
city: Breda
country: Netherlands
facility: Research Centre NL-008
city: Eindhoven
country: Netherlands
facility: Research Centre NL-009
city: Leeuwarden
country: Netherlands
facility: Research Centre NL-002
city: Rotterdam
country: Netherlands
facility: Research Centre NL-003
city: Chrzanow
country: Poland
facility: Research Centre PL-002
city: Kędzierzyn- Koźle
country: Poland
facility: Research Centre PL-005
city: Warsaw
country: Poland
facility: Research Centre NL-009
city: Barcelona
country: Spain
facility: Research Centre ES-003
city: Barcelona
country: Spain
facility: Research Centre ES-005
city: Madrid
country: Spain
facility: Research Centre ES-012
city: Vigo
country: Spain
facility: Research Centre ES-018
city: Belfast
country: United Kingdom
facility: Research Centre GB-021
city: Cardiff
country: United Kingdom
facility: Research Centre GB-002
city: Cottingham
country: United Kingdom
facility: Research Centre GB-010
city: London
country: United Kingdom
facility: Research Centre GB-022
city: Newcastle-Upon-Tyne
country: United Kingdom
facility: Research Centre GB-013
city: Stevenage
country: United Kingdom
facility: Research Centre GB-012
Study officials:
affiliation: International Center for Circulatory Health, NHLI, Imperial College, London, United Kingdom
name: P. W. Serruys, Prof. MD.
role: STUDY_CHAIR
affiliation: Fortis Escorts Heart Institute & Research Centre, New Delhi, India
name: U. Kaul, Prof. MD.
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum, Amsterdam, The Netherlands
name: R. de Winter, Prof. MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiac Catheter Laboratories, Royal Freeman, Newcastle, United Kingdom
name: A. Zaman, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: ECRI-Trials B.V. (E.Spitzer@ECRI-Trials.com)
name: Ernest Spitzer, MD.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.