Status:
RECRUITING
Coroflex® ISAR NEO PMCF Study
Lead Sponsor:
Fundación EPIC
Conditions:
Coronary Artery Disease (CAD)
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 sys...
Detailed Description
The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex...
Eligibility Criteria
Inclusion
- 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/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND
- Patients with Novo lesion length 2-4 mm AND
- Informed consent signed
Exclusion
- Patients with express refusal by the patient to participate in the study.
- Patients pregnant women and lactating women.
- Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
- Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
- Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
- Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
- Patients with known sensitivity to contrast agents who cannot be premedicated.
- Patients with contraindications or hypersensitivity to sirolimus
- Patients with a life expectancy of less than 2 years
- Patients included in other clinical trials
Key Trial Info
Start Date :
August 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT05698732
Start Date
August 4 2023
End Date
February 1 2027
Last Update
February 17 2026
Active Locations (20)
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1
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France, 13100
2
Centre Hospitalier Ajaccio
Ajaccio, France, 20090
3
CH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
4
University Hospital Center of Caen
Caen, France, 14000