An interventional study of SUPRAFLEX and XIENCE in Coronary Stenosis, sponsored by ECRI bv. Completed at 23 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by ECRI bv · Not applicable, Interventional, and Treatment
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.
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.
302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.
This study's enrollment of 1,435 is above the median of 200 across 160 interventional studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →ECRI bv is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All comers" patients:
Exclusion Criteria:
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 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
Percutaneous Coronary Intervention
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.
Time frame: 12 months post-procedure
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
Plan to share: Undecided — 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.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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