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| Name | Class |
|---|---|
| Sahajanand Medical Technologies Limited | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUPRAFLEX | Device | Percutaneous Coronary Intervention |
| |
| XIENCE |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
All comers" patients:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centre BG-004 | Plovdiv | Bulgaria | ||||
| Research Centre BG-001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35285804 | Derived | 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. | |
| 34666500 |
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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.
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| Device |
Percutaneous Coronary Intervention |
|
| 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 |
| Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR. | 30 days, 6 months, 1 year, 2 years and 3 years |
| Stent thrombosis rates according to ARC classification | 30 days, 6 months, 1 year, 2 years and 3 years |
| Sofia |
| Bulgaria |
| Research Centre HU-002 | Budapest | Hungary |
| Research Centre HU-001 | Szeged | Hungary |
| Research Centre IT-001 | Milan | Italy |
| Research Centre NL-007 | Amsterdam | Netherlands |
| Research Centre NL-008 | Breda | Netherlands |
| Research Centre NL-009 | Eindhoven | Netherlands |
| Research Centre NL-002 | Leeuwarden | Netherlands |
| Research Centre NL-003 | Rotterdam | Netherlands |
| Research Centre PL-002 | Chrzanów | Poland |
| Research Centre PL-005 | Kędzierzyn-Koźle | Poland |
| Research Centre NL-009 | Warsaw | Poland |
| Research Centre ES-003 | Barcelona | Spain |
| Research Centre ES-005 | Barcelona | Spain |
| Research Centre ES-012 | Madrid | Spain |
| Research Centre ES-018 | Vigo | Spain |
| Research Centre GB-021 | Belfast | United Kingdom |
| Research Centre GB-002 | Cardiff | United Kingdom |
| Research Centre GB-010 | Cottingham | United Kingdom |
| Research Centre GB-022 | London | United Kingdom |
| Research Centre GB-013 | Newcastle upon Tyne | United Kingdom |
| Research Centre GB-012 | Stevenage | United Kingdom |
| 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. |
| 30827782 | 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. |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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