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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT01071460
Eligibility Criteria:
Inclusion Criteria:
* Subjects, male or female, must be between the ages of 35 to 85 years inclusive at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test at Screening.
* Subjects must give written informed consent prior to participation in the study and must understand the purpose of this study and be willing to adhere to the study procedures described in this protocol.
* Rutherford Classification Category 2-4
* Single de novo lesion in the superficial femoro/popliteal artery
* Disease segment length ≤150mm
-\>70% diameter stenosis and occlusion
* Patent ipsilateral iliac artery
* Patent ipsilateral popliteal artery and at least 1 patent tibial artery in continuity to ankle
* Target reference vessel diameter 3.5-7.5 mm
Exclusion Criteria:
* Target lesion previously treated with a stent or surgery.
* Rutherford Classification Category 0,1,5 or 6.
* Inability to tolerate antithrombotic or antiplatelet therapies.
* Pregnancy.
* Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
* Serum creatinine \> 2.5 mg/dL.
* Myocardial infarction or stroke within 90 days of enrollment.
* Hypercoagulable state.
* Uncontrollable hypertension.
* Patients currently enrolled in any other clinical trial(s).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT01071460
Study Brief:
Protocol Section:
NCT01071460