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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT02730234
Eligibility Criteria:
Inclusion Criteria:
1. Patients with symptomatic peripheral arterial disease (Rutherford Becker Class II to IV)
2. Previously treated with stenting in the femoropopliteal segment
3. No limit on how many times the target in-stent restenotic lesion has been previously treated.
4. There is no exclusion based on how the prior treatment was done including if drug eluting balloons or stents have been used. Covered stents cannot be included
5. There is no limit on the length of the target lesion as long as only one target lesion is treated and enrolled
Exclusion Criteria:
Subjects must meet all of the following criteria to be eligible to participate in this study:
1. Subject is 18 years of age or older.
2. Subject presents with clinical evidence of peripheral arterial disease with ISR in the femoropopliteal segment (includes common femoral, superficial femoral and popliteal)
3. Subject presents with a Rutherford Classification of 2-4 and has symptoms of rest limb pain or claudication.
4. Target lesion(s) must be viewed angiographically and have ≥50% stenosis.
5. The atherectomy wire must be placed entirely across all lesions to be treated with no visible evidence of clear or suspected subintimal/substent wire passage.
6. The main target vessel reference diameter must be \> or = 5 mm and ≤ 7 mm
7. One patent distal run-off vessel with \<70% disease and with brisk flow is required.
8. Intraluminal crossing of the lesion. If this is not certain, IVUS may be used to verify this per operator's discretion
9. Patient has signed approved informed consent.
10. Patient is willing to comply with the follow-up evaluations at specified times.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02730234
Study Brief:
Protocol Section:
NCT02730234