Ischemic Heart Disease Clinical Trial
— MultiflexOfficial title:
SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
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).
Status | Recruiting |
Enrollment | 508 |
Est. completion date | October 1, 2025 |
Est. primary completion date | December 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - = 18 years old and; - Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use - Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries. - Substudy: Patients with Ejection Fraction <45% by Echocardiography - Informed consent signed Exclusion Criteria: - Not meet inclusion criteria - Contraindication for antiplatelet treatment - Patient life expectancy less than 12 months |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de Cruces | Barakaldo | |
Spain | Hospital de La Santa Creu I Sant Pau | Barcelona | |
Spain | Hospital Universitari Vall D'Hebron | Barcelona | |
Spain | Hospital Universitario San Pedro de Alcántara | Cáceres | |
Spain | Hospital General Universitario de Castellón | Castelló | |
Spain | Hospital General Universitario de Ciudad Real | Ciudad Real | |
Spain | Hospital Universitario A Coruña | Coruña | |
Spain | Hospital General Universitario de Elche | Elche | Alicante |
Spain | Hospital Universitari Dr. Josep Trueta | Girona | |
Spain | Hospital Universitario Clínico San Cecilio | Granada | |
Spain | Hospital Universitario de Leon | León | |
Spain | Hospital Universitari Arnau de Vilanova | Lleida | |
Spain | Hospital Universitario 12 de Octubre | Madrid | |
Spain | Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | |
Spain | Hospital Parc Tauli | Sabadell | |
Spain | Hospital Clinico Universitario de Salamanca | Salamanca | |
Spain | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela | |
Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
Spain | Hospital Universitario de Toledo | Toledo | |
Spain | Hospital Universitario Y Politécnico La Fé | Valencia | |
Spain | Hospital Universitario Lozano Blesa | Zaragoza |
Lead Sponsor | Collaborator |
---|---|
Fundación EPIC |
Spain,
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. — View Citation
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. — View Citation
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target Lesion Failure (TLF) | Rate of target lesion failure | 12 months | |
Primary | 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 | |
Secondary | Major Adverse Cardiovascular Event (MACE) | Composite event of cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke | 12 months | |
Secondary | Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography | In the subgroup of patients with reduced Ejection Fraction, Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography | 1 month | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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