Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Completed · Not applicable

Conditions studied: Ischemia

In brief

The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries was terminated. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.

Key facts

Study ID: NCT02758847
Run by: Rabih A. Chaer
People needed: 50
Starts: 2016-09-01
Expected to finish: 2022-12-31
Last updated by the study team: 2024-04-25

Who can join

Age: 40 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient population: all patients with CLI (critical limb ischemia) and tissue loss scheduled for endovascular intervention for femoral popliteal occlusive or multilevel disease.
Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an Ethical Committee approved consent form
Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 5 or 6
General Angiographic Inclusion Criteria
Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in the SFA and/or popliteal arteries.
Iliac inflow or Tibial outflow interventions can be done at the discretion of the investigator with standard balloon Percutaneous Transluminal Angioplasty (PTA)

You may not qualify if…

Patient unwilling or unlikely to comply with Follow-Up schedule
Aneurysm in the target vessel
Acute thrombus in the target limb
Sensitivity to Paclitaxel
Immunosuppressed patients (transplant, chemotherapy, etc.)

Where it is running

Judith Brimmeier — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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