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Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding. The new generation of ultrathin strut sirolimus-eluting stent with bioabsorbable polymer allow for shorter antiplatelets regimens and could be a good option for this high-bleeding risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supraflex Cruz Sirolimus-eluting Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraflex Cruz Sirolimus-eluting Stent | Device | PCI with SupraFlex Cruz® stent in de novo coronary stenosis of patients under chronic oral anticoagulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NACE (Net Adverse Clinical Events) | Combined endpoint of Cardiac Death, Acute Myocardial Infarction, Stroke, Need for new Treated Vessel Revascularization (TVR) and BARC (Bleeding Academic Research Consortium) 3-5 | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| MACE (Major Adverse Cardiac Events) | To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer. | 12 months |
| MACE (Major Adverse Cardiac Events) |
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Inclusion Criteria:
Patients must meet all inclusion criteria:
Exclusion Criteria:
Patients do not have to meet any exclusion criteria
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Patients under chronic oral anticoagulation undergoing PCI with implantation of a SupraFlex Cruz(r) stent
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Gabriel Córdoba Soriano, MD, PhD | Contact | 0034 967597532 | jgcordoba@foroepic.org | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Albacete | Recruiting | Albacete | 02008 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26888727 | Background | Lemos PA, Chandwani P, Saxena S, Ramachandran PK, Abhyankar A, Campos CM, Marchini JF, Galon MZ, Verma P, Sandhu MS, Parikh N, Bhupali A, Jain S, Prajapati J. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open. 2016 Feb 17;6(2):e010028. doi: 10.1136/bmjopen-2015-010028. | |
| 31604782 |
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To assess the occurrence of major adverse cardiac events (MACE) in patients receiving chronic oral anticoagulation who have been treated with ultrathin strut Sirolimus-eluting stents with bioabsorbable polymer. |
| 6 months |
| TLF (Target Lesion Failure) | To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation. | 12 months |
| TLF (Target Lesion Failure) | To assess the failure rate of the lesion treated (TLF) with ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer in patients receiving chronic oral anticoagulation. | 6 months |
| Death | To assess the occurrence of Death | 12 months |
| Death | To assess the occurrence of Death | 6 months |
| Acute Myocardial Infarction (AMI) | To assess the occurrence of AMI | 12 months |
| Acute Myocardial Infarction (AMI) | To assess the occurrence of AMI | 6 months |
| Stroke | To assess the occurrence of Stroke | 12 months |
| Stroke | To assess the occurrence of Stroke | 6 months |
| Target vessel revascularization (TVR) | To assess the occurrence of TVR | 12 months |
| Target vessel revascularization (TVR) | To assess the occurrence of TVR | 6 months |
| Hospital Universitario San Juan de Alicante |
| Recruiting |
| Alicante |
| 03550 |
| Spain |
| Hospital General Universitario de Merida | Recruiting | Badajoz | 6800 | Spain |
| Hospital General Universitari de Castelló | Recruiting | Castelló | 12004 | Spain |
| H.G.U. de Ciudad Real. | Recruiting | Ciudad Real | 13005 | Spain |
| Hospital General Universitari d'Elx | Recruiting | Elche | 03203 | Spain |
| Hospital Universitario de Canarias | Recruiting | Laguna | 38320 | Spain |
| Hospital Doctor Jose Molina Orosa | Recruiting | Las Palmas de Gran Canaria | 35500 | Spain |
| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | 28222 | Spain |
| Hospital Universitario de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hospital General de Fuerteventura | Recruiting | Puerto del Rosario | 35600 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| Background |
| Choudhury A, Garg S, Smith J, Sharp A, Nabais de Araujo S, Chauhan A, Patel N, Wrigley B, Chattopadhyay S, Zaman AG. Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months' results from the S-FLEX UK registry. BMJ Open. 2019 Oct 11;9(10):e026578. doi: 10.1136/bmjopen-2018-026578. |
| 30827782 | Background | 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. |
| 37634150 | Background | Biscaglia S, Guiducci V, Escaned J, Moreno R, Lanzilotti V, Santarelli A, Cerrato E, Sacchetta G, Jurado-Roman A, Menozzi A, Amat Santos I, Diez Gil JL, Ruozzi M, Barbierato M, Fileti L, Picchi A, Lodolini V, Biondi-Zoccai G, Maietti E, Pavasini R, Cimaglia P, Tumscitz C, Erriquez A, Penzo C, Colaiori I, Pignatelli G, Casella G, Iannopollo G, Menozzi M, Varbella F, Caretta G, Dudek D, Barbato E, Tebaldi M, Campo G; FIRE Trial Investigators. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction. N Engl J Med. 2023 Sep 7;389(10):889-898. doi: 10.1056/NEJMoa2300468. Epub 2023 Aug 26. |
| 37708755 | Background | Paradies V, Maurina M, Tonino P, Hofma SH, Vos J, van Kuijk JP, Oemrawsingh RM, Mafragi AA, Spano F, Pisters R, Polad J, Ijsselmuiden S, Cambero MM, Smits PC. Comparison of Supraflex Cruz 60 mum Versus Ultimaster Tansei 80 mum Stent Struts in High Bleeding Risk PCI Patients: Study design and Rational of Compare 60/80 HBR trial. Am J Cardiol. 2023 Nov 1;206:230-237. doi: 10.1016/j.amjcard.2023.08.046. Epub 2023 Sep 13. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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