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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01246505
Eligibility Criteria:
Inclusion Criteria:
* suitable candidate for non-emergent, peripheral angioplasty
* documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
* limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery
Exclusion Criteria:
* intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
* appearance of thrombus or intraluminal filling defects
* peripheral intervention in the target limb within two weeks of the procedure
* renal insufficiency (serum creatinine of \> 2.3 mg/dl)
* contraindication to a peripheral artery intervention
* participation in another investigational protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01246505
Study Brief:
Protocol Section:
NCT01246505