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

Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

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.

Study Overview

• Status: Completed
• Conditions: Ischemia
• Intervention / Treatment: Device: Angiogram, Medtronic DCB (paclitaxel)/stent; Device: Angiogram, Bard DCB (paclitaxel)/stent

Detailed Description

Although the association between the drug coated balloon (DCB) therapy and limb outcomes could not be clearly linked to the use of antiproliferative agents, the findings of paclitaxel crystals downstream of the treated lesions, although in small amounts, has raised concerns about the safety of such therapy in patients with critical limb ischemia (CLI) and tissue loss.

These concerns, however, may not translate to patients with femoropopliteal occlusive disease as the amount of paclitaxel reaching the foot may be even smaller after being filtered by the calf musculature.

Since the use of DCB angioplasty in the Superficial Femoral Artery (SFA) and popliteal has been shown to deliver significantly more durable outcomes compared to standard angioplasty alone, with reported primary patency rates of almost 90% at one year, this therapy may even be more needed in patients with tissue loss where prolonged patency is essential for wound healing.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15237
      • Judith Brimmeier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Critical Limb Ischemia (CLI) and Tissue Loss; 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; 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.; Device: Angiogram, Bard DCB (paclitaxel)/stent; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Patency ( Determine if Vessel Remains Open)	Prospective duplex ultrasound will be performed at the listed interval to verify (primary and secondary) patency of targeted vessels. Primary patency is defined as the target vessel "patency obtained without the need for additional or secondary surgical or endovascular procedures (the interval from the time of the original intervention until any intervention designed to maintain or re-establish patency is performed)."	6 months

Collaborators and Investigators

• Sponsor: Rabih A. Chaer
• Investigators: Principal Investigator: Rabih A Chaer, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimated): May 3, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: critical lower limb ischemia with tissue loss
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: PRO15120093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: still early in the recruitment process

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes