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RecruitingCoronary Artery Disease (CAD)Ischemic Heart Disease

SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Eligible age

18+ yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

No

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About this 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).

Sponsor: Fundación EPIC

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

Source: ClinicalTrials.gov · NCT05617599 · last updated 2025-12-16