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

NCT02758847 | Completed Results DMC FDA Device

• 1 other identifier: PRO15120093
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemia

Keywords

critical lower limb ischemia with tissue loss

Outcome Measures

Primary Outcomes (2)

• Wound Healing

  Percentage of participants with wound healing defined as \> 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.

  12 months

• Amputation Free Survival

  Percentage of participants with a 6 month amputation free survival.

  6 months

Secondary Outcomes (1)

• Primary Patency ( Determine if Vessel Remains Open)

  6 months

Study Arms (1)

Critical Limb Ischemia (CLI) and Tissue Loss

OTHER

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Patients with CLI will receive either Angiogram, Medtronic DCB (paclitaxel)/stent or Angiogram, Bard DCB (paclitaxel)/stent

Device: Angiogram, Medtronic DCB (paclitaxel)/stent; Device: Angiogram, Bard DCB (paclitaxel)/stent

Interventions

Angiogram, Medtronic DCB (paclitaxel)/stent DEVICE

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.

Critical Limb Ischemia (CLI) and Tissue Loss

Angiogram, Bard DCB (paclitaxel)/stent DEVICE

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.

Critical Limb Ischemia (CLI) and Tissue Loss

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.)

Sponsors & Collaborators

• Rabih A. Chaer: lead

Study Sites (1)

Judith Brimmeier

Pittsburgh, Pennsylvania, 15237, United States

Location

MeSH Terms

Conditions

Ischemia

Interventions

Angiography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Results Point of Contact

• Title: Dr Rabih Chaer
• Organization: University of Pittsburgh

chaerra@upmc.edu

4128023333

Study Officials

• Rabih A Chaer, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: May 3, 2016
• Study Start: September 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 25, 2024
• Results First Posted: April 25, 2024

Record last verified: 2024-04

Locations

US (1)