N/A
N=50
Evaluation of Paclitaxel in Patients With CLI and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT02758847 ↗Enrolled (actual)
50
Serious AEs
22.0%
Results posted
Apr 2024
Primary outcome: Primary: Wound Healing — 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Angiogram, Medtronic DCB (paclitaxel)/stent (Device); Angiogram, Bard DCB (paclitaxel)/stent (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Rabih A. Chaer
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Healing |
30 | — |
| PRIMARY Amputation Free Survival |
71.4 | — |
| SECONDARY Primary Patency ( Determine if Vessel Remains Open) |
97 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.)
Data sourced from ClinicalTrials.gov (NCT02758847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.