SUPRAFLEX CRUZ PMCF Study ( rEpic05 )
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SUPRAFLEX CRUZ.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease (CAD), Ischemic Heart Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
Overview
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).
Detailed description
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.
Interventions
- Device SUPRAFLEX CRUZ
Patients in whom treatment with SUPRAFLEX CRUZ has been attempted
Primary outcome measures
- Target Lesion Failure (TLF) [Time frame: 12 months]
- Device-oriented Composite Endpoint (DoCE) [Time frame: 12 months]
Secondary outcome measures (5)
- Major Adverse Cardiovascular Event (MACE) [Time frame: 12 months]
- Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography [Time frame: 1 month]
- Change from baseline in Global Longitudinal Strain measured by strain-rate echocardiography [Time frame: 1 month]
- Change of segmental movement of the territory revascularized measured by echocardiography [Time frame: 1 month]
- Changes in left ventricular ejection fraction (LVEF) [Time frame: 1 month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 21 centers
- Hospital General Universitario de Elche — Elche
- Hospital Universitario A Coruña — A Coruña
- Hospital Universitario de Cruces — Barakaldo
- Hospital Universitari Vall D'Hebron — Barcelona
- Hospital de La Santa Creu I Sant Pau — Barcelona
- Hospital General Universitario de Castellón — Castelló
- Hospital Universitario San Pedro de Alcántara — Cáceres
- Hospital General Universitario de Ciudad Real — Ciudad Real
- … and 13 more centers
Publications
- 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. PMID 29945934
- 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-2015-01 PMID 26888727
- 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 PMID 30066672
- 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 cor PMID 30827782
Identifiers
NCT: NCT05617599 · rEpic05 - Multiflex