| NCT ID | NCT05698732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease (CAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2023-08-04 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2023-08-04 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05698732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05698732 currently recruiting?
Yes, NCT05698732 is actively recruiting participants. Contact the research team at koldobikags@hotmail.com for enrollment information.
Where is the NCT05698732 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Ajaccio, France, Bordeaux, France, Caen, France and 11 additional locations.
Who is sponsoring the NCT05698732 clinical trial?
NCT05698732 is sponsored by Fundación EPIC. The trial plans to enroll 3,000 participants.