Coroflex® ISAR NEO PMCF Study
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
Fundación EPIC
3,000 participants
Aug 4, 2023
OBSERVATIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05698732