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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT02717104
Eligibility Criteria:
Inclusion Criteria:
* ≥19 years of age
* Rutherford Clinical Category ≥4
* Patient or Legally Authorized Representative is willing to provide informed consent and comply with the required follow-up
* Stenotic or obstructive vascular lesions in femoropopliteal artery(s)
* Lesion(s) can be treated with available LUTONIX Drug Coated Balloon Catheter device size matrix per current IFU
* At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with the LUTONIX Drug Coated PTA Dilatation Catheter)
Exclusion Criteria:
* Patient is currently participating in an active phase of another investigational drug or device study
* Inability to take recommended medications as stated in the IFU or non-controllable allergy to contrast
* Known inadequate distal outflow or planned future (within 30 days) treatment of vascular disease distal to the target lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02717104
Study Brief:
Protocol Section:
NCT02717104