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Post-market follow-up of Coroflex® ISAR NEO coronary stent system

Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

Observational Fundación EPIC · NCT05698732

This study is testing how safe and effective the Coroflex® ISAR NEO stent is for patients who need it in real-life situations.

Quick facts

Study typeObservational
Enrollment3000 (estimated)
Ages18 Years and up
SexAll
SponsorFundación EPIC Academic / other
Locations22 sites (Aix-en-Provence and 21 other locations)
Trial IDNCT05698732 on ClinicalTrials.gov

What this trial studies

This international, multicenter, prospective, non-randomized study aims to confirm the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system in real-world patients. It will involve consecutive patients treated with the sirolimus-eluting stent to ensure compliance with EU Medical Device regulations. The study will gather data under daily clinical practice conditions to evaluate the stent's effectiveness and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who meet the standard recommendations for Percutaneous Coronary Intervention and have specific lesion characteristics.

Not a fit: Patients who are pregnant, lactating, or have acute coronary syndrome in cardiogenic shock will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of the Coroflex® ISAR NEO stent's safety and performance, potentially leading to improved treatment options for patients with coronary artery disease.

How similar studies have performed: Other studies have successfully evaluated similar stent systems, indicating a potential for positive outcomes in this approach.

Eligibility criteria

Show full inclusion / exclusion 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/ 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 Criteria:

* 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

Where this trial is running

Aix-en-Provence and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseIschemic Heart DiseaseMDRPMCFDrug Eluting Stent
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.