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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT00712257
Eligibility Criteria:
Inclusion Criteria:
* Subject or subject's legal representative informed of the study nature.
* Subject understands the duration of the study and its follow up visit requirements.
* Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
* Subject able to walk unassisted.
* Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.
Exclusion Criteria:
* Life expectancy less than 12 months
* Myocardial infarction less than 3 months prior to procedure
* Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
* Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
* Uncontrolled hypercoagulability
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT00712257
Study Brief:
Protocol Section:
NCT00712257