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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01083394
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
Exclusion Criteria:
* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Not at least one vessel run-off
* Popliteal involvement with stenosis \>70%
* Severe renal insufficiency (GFR \<30 ml/min/m2)
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01083394
Study Brief:
Protocol Section:
NCT01083394