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:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT06056193
Eligibility Criteria:
Inclusion Criteria
* Age at least 18 years
* Informed consent with signature
* Rutherford category 2 or 3 (in terms of lifestyle-limiting moderate or severe claudication symptomatology) or chronic critical ischemia (Rutherford 4-6)
* Venous bypass stenosis requiring intervention
* Confirmed inflow
* At least 1 crural outflow vessel
Exclusion Criteria:
* Pregnant or lactating women
* Active infection or sepsis
* Patients currently participating in another clinical trial
* Unconfirmed inflow
* Intolerance to sirolimus
* Coagulopathy
* Radiotherapy
* Patients on immunosuppressive therapy
* Non-dialysis renal insufficiency (eGFR \< 45 ml/min/1.73m2)
* Use of potent CYP3A4 and/or P-gp inhibitors (such as ketoconazole, Voriconazole, itraconazole, erythromycin, telithromycin, or clarithromycin) or strong CYP3A4 and/or P-gp inducers (such as rifampin or rifabutin).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06056193
Study Brief:
Protocol Section:
NCT06056193