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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT00123292
Eligibility Criteria:
Inclusion Criteria:
* Patients presenting within 14 days of onset of acute thrombotic or embolic arterial occlusion of a lower extremity (native vessel or bypass graft).
* Complete occlusion of infrarenal vessel or bypass graft, as determined by angiography.
* Lower extremity ischemia graded as SVS/ISCS (Society of Vascular Surgery/ International Society for Cardiovascular Surgery) class I or II (a or b).
* Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception).
Exclusion Criteria:
* Profound ischemia with permanent motor paresis or sensory loss (or ischemic process deemed irreversible, i.e. class III).
* Occlusion not penetrable by the infusion guide wire.
* Known or suspected allergy to contrast agents or heparin sodium.
* Active bleeding or known hemorrhagic diathesis.
* Stroke in the previous 6 months or transient ischemic attack in the previous 2 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00123292
Study Brief:
Protocol Section:
NCT00123292