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Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the SUPRAFLEX CRUZ in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Artery Disease (CAD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUPRAFLEX CRUZ | Device | Patients in whom treatment with SUPRAFLEX CRUZ has been attempted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Rate of target lesion failure | 12 months |
| Device-oriented Composite Endpoint (DoCE) | Device-oriented Composite Endpoint (DoCE) defined as the composite of: Cardiovascular death, target vessel myocardial infarction, clinically indicated repeat revascularization of the target lesion at 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Event (MACE) | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke | 12 months |
| Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with MULTIFLEX PMCF according to routine hospital practice and following instructions for use
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Garcia, MD, PhD | Contact | 0034932746155 | brunogb51@gmail.com | |
| FUNDACION EPIC | Contact | 0034987225638 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Recruiting | Elche | Alicante | 03203 | Spain | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29945934 | Background | Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-Generation Ultrathin Strut Drug-Eluting Stents Versus Older Second-Generation Thicker Strut Drug-Eluting Stents for Coronary Artery Disease. Circulation. 2018 Nov 13;138(20):2216-2226. doi: 10.1161/CIRCULATIONAHA.118.034456. | |
| 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography |
| 1 month |
| Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography | In the subgroup of patients with reduced Ejection Fraction, Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography | 1 month |
| Change of segmental movement of the territory revascularized measured by echocardiography | In the subgroup of patients with reduced Ejection Fraction, Change from baseline segmental movement of the territory revascularized measured by echocardiography | 1 month |
| Changes in left ventricular ejection fraction (LVEF) | Changes in left ventricular ejection fraction (LVEF) from baseline and from 1 month post-procedure/pre-hospital discharge as assessed by echo in the subgroup of ventricular dysfunction | 1 month |
| Hospital Universitario A Coruña |
| Recruiting |
| A Coruña |
| 15006 |
| Spain |
| Hospital Universitario de Cruces | Recruiting | Barakaldo | 48903 | Spain |
| Hospital Universitari Vall D'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital de La Santa Creu I Sant Pau | Recruiting | Barcelona | 08041 | Spain |
| Hospital General Universitario de Castellón | Recruiting | Castelló | 12004 | Spain |
| Hospital Universitario San Pedro de Alcántara | Recruiting | Cáceres | 10003 | Spain |
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
| Hospital Universitari Dr. Josep Trueta | Recruiting | Girona | 17007 | Spain |
| Hospital Universitario Clínico San Cecilio | Recruiting | Granada | 18016 | Spain |
| Hospital Universitario de Leon | Recruiting | León | 24001 | Spain |
| Hospital Universitari Arnau de Vilanova | Recruiting | Lleida | 25198 | Spain |
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Recruiting | Murcia | 30120 | Spain |
| Hospital Parc Tauli | Recruiting | Sabadell | 08208 | Spain |
| Hospital Clinico Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hospital Clínico Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario de Toledo | Recruiting | Toledo | 45007 | Spain |
| Hospital Universitario Y Politécnico La Fé | Recruiting | Valencia | 46026 | Spain |
| Hospital Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| 30066672 | Background | Modolo R, Chichareon P, Kogame N, Asano T, Chang CC, de Winter RJ, Kaul U, Zaman A, Spitzer E, Takahashi K, Katagiri Y, Soliman OII, van Es GA, Morel MA, Onuma Y, Serruys PW. A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial. EuroIntervention. 2019 Jul 20;15(4):e362-e369. doi: 10.4244/EIJ-D-18-00499. |
| 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. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |