SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Recruiting now

Conditions studied: Coronary Artery Disease (CAD), Ischemic Heart Disease

In brief

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).

Key facts

Study ID

NCT05617599

Run by

Fundación EPIC

People needed

508

Starts

2023-05-10

Expected to finish

2026-12-01

Last updated by the study team

2025-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• Not meet inclusion criteria
• Contraindication for antiplatelet treatment
• Patient life expectancy less than 12 months

Where it is running

• Hospital General Universitario de Elche — Elche, Alicante, Spain (enrolling)
• Hospital Universitario A Coruña — A Coruña, Spain (enrolling)
• Hospital Universitario de Cruces — Barakaldo, Spain (enrolling)
• Hospital Universitari Vall D'Hebron — Barcelona, Spain (enrolling)
• Hospital de La Santa Creu I Sant Pau — Barcelona, Spain (enrolling)
• Hospital General Universitario de Castellón — Castelló, Spain (enrolling)
• Hospital Universitario San Pedro de Alcántara — Cáceres, Spain (enrolling)
• Hospital General Universitario de Ciudad Real — Ciudad Real, Spain (enrolling)
• Hospital Universitari Dr. Josep Trueta — Girona, Spain (enrolling)
• Hospital Universitario Clínico San Cecilio — Granada, Spain (enrolling)
• Hospital Universitario de Leon — León, Spain (enrolling)
• Hospital Universitari Arnau de Vilanova — Lleida, Spain (enrolling)
• Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
• Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (enrolling)
• Hospital Parc Tauli — Sabadell, Spain (enrolling)
• Hospital Clinico Universitario de Salamanca — Salamanca, Spain (enrolling)
• Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela, Spain (enrolling)
• Hospital Universitario Virgen Del Rocio — Seville, Spain (enrolling)
• Hospital Universitario de Toledo — Toledo, Spain (enrolling)
• Hospital Universitario Y Politécnico La Fé — Valencia, Spain (enrolling)
• Hospital Universitario Lozano Blesa — Zaragoza, Spain (enrolling)

Full record on ClinicalTrials.gov

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