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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT00561457
Eligibility Criteria:
Inclusion Criteria:
* Patient or legal guardian understands procedure and provides written informed consent prior to study participation.
* Patient must be able and willing to comply with all study procedures including scheduled follow-up visits and diagnostic tests.
* Lesion(s) distinctly localized in the common and/or external iliac arteries.
* Reference lumen diameter (RLD) 6 mm and 9 mm.
* Stenosis 30% and symptomatic ischemic disease (Category 1-6 Chronic Limb Ischemia or Threatened or Irreversible Acute Limb Ischemia).
Exclusion Criteria:
* Patients diagnosed with preoperative coagulation disorder or with contraindications to antiplatelet or anticoagulant therapy.
* Patients who are pregnant or planning to become pregnant during the clinical investigation.
* Patients with a life expectancy \< 3 years.
* Patients currently or scheduled to be enrolled in another investigation that conflicts with follow-up testing or may confound the study data.
* Patients with absolute contraindication to x-ray contrast media or medications normally administered during an interventional procedure.
* Patients with severe tortuosity or angulation of a vessel that may prevent access in the opinion of the investigator.
* The presence of soft, thrombotic or embolic material within or adjacent to the lesion(s) being treated with the study device, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00561457
Study Brief:
Protocol Section:
NCT00561457