Coroflex® ISAR NEO PMCF Study
Recruiting
Observational Study
Coronary Artery Disease (CAD)
Ischemic Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 3,000 (estimated)
- Sponsor
- Fundación EPIC · Other
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About This Trial
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Coroflex® ISAR NEO is intended to be used for
* Patients must be at least 18 years of age AND
* The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ …
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