Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT05698732
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05698732
Study Brief:
Protocol Section:
NCT05698732