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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT00311805
Eligibility Criteria:
Inclusion Criteria:
* Males or females equal to or greater than 21 years old
* Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable.
* Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3).
* Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months.
Exclusion Criteria:
* Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening.
* Patients with iliac disease amenable to revascularization.
* Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed.
* Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6.
* Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00311805
Study Brief:
Protocol Section:
NCT00311805