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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT04304105
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be ≥18 years of age
2. Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target
3. Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups.
Exclusion Criteria:
1. Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
2. Subject is participating in the PROMISE II Clinical Trial.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04304105
Study Brief:
Protocol Section:
NCT04304105