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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT01355406
Eligibility Criteria:
Inclusion Criteria:
All subjects must meet the following criteria:
1. Subjects, male or female, must be at least 35 years of age at the time of consent. A female of childbearing potential may be enrolled, provided she has a negative pregnancy test within 7 days of screening.
2. 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.
3. Rutherford Classification Category 2-4
4. De novo lesion in the Femoropopliteal artery, including the entire extent of the superficial femoral artery and the proximal portion of the popliteal artery extending to the medial condyle 3 cm above the knee joint
5. Disease segment length ≤ 180 mm
6. \>70% diameter stenosis and/or occlusion based on site-determined visual angiography
7. Patent ipsilateral iliac artery
8. Patency of ipsilateral mid/distal popliteal artery and at least 1 tibial artery with no planned intervention
9. Target reference vessel diameter 3.5-7.5 mm.
10. Projected life expectancy of 12 months or greater
11. Patient is available for follow-up for 36 months and is willing and able to comply with all follow-up requirements
12. Patient is willing and able to provide signed informed consent
Exclusion Criteria:
Any subject meeting any of the following criteria will be excluded from the study.
1. Target vessel previously treated with a stent
2. Target lesion within 1.5 cm of the ostium of the SFA
3. Rutherford Classification Category 0,1,5 or 6
4. Inability to tolerate antithrombotic or antiplatelet therapies
5. Pregnancy (female of child-bearing age confirmed pregnant)
6. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of complying with protocol follow up.
7. Serum creatinine \> 2.5 mg/dL
8. Myocardial infarction or stroke within 30 days of treatment date
9. Known hypercoagulable state
10. Known bleeding diathesis
11. Untreated angiographically-evident thrombus in target vessel
12. Patients currently enrolled in any other clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT01355406
Study Brief:
Protocol Section:
NCT01355406