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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00912756
Eligibility Criteria:
Patient criteria:
* Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area\*
* Patients who can be monitored for at least 2 years after surgery
Lesion criteria:
* Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions that are 30 cm long or less if stented
* At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.
* Occlusive lesions may be included.
Exclusion criteria:
* Patients with or at risk of hemorrhagic complications or patients with bleeding tendency
* Patients with congestive cardiac failure
* Patients with a drug-eluting stent
* Patients with acute lower limb ischemia
* Patients with creatinine of 2 mg/dL or more(without dialysis)
* patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug.
Lesion criteria:
* Remnant inflow
* Severe calcification
* No arterial runoff below the knee
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00912756
Study Brief:
Protocol Section:
NCT00912756