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Trial record 30 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

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

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ClinicalTrials.gov Identifier: NCT02758847
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rabih A. Chaer, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Ischemia Device: Angiogram, Medtronic DCB (paclitaxel)/stent Device: Angiogram, Bard DCB (paclitaxel)/stent Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty
Actual Study Start Date : September 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Wound Healing [ Time Frame: 12 months ]
    Percentage of participants with wound healing defined as > 50% area/volume reduction of baseline ulcer(s) in the treated leg at 1 year.

  2. Amputation Free Survival [ Time Frame: 12 months ]
    Percentage of participants with a 1 year amputation free survival.


Secondary Outcome Measures :
  1. Primary Patency ( determine if vessel remains open) [ Time Frame: 3, 6, 12 months ]
    Prospective duplex ultrasound will be performed at the intervals listed to verify (primary and secondary) patency of targeted vessels. Assessment of severe restenosis and reinterventions will be determined

  2. Rate of severe stenosis (narrowing) and reinterventions [ Time Frame: 12 months ]
    Severe stenosis (>50%) evaluated by Duplex ultrasound at 1,3,6 and 12 month intervals



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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758847


Contacts
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Contact: Robin Brown, BA 412-235-1304 brownrl7@upmc.edu
Contact: Ali Arak, BS 412-623-8443 araka@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center, Division of Vascular Surgery Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Ali Arak, BS    412-623-8443    araka@upmc.edu   
Contact: Robin Brown    412-235-1303    brownrl7@upmc.edu   
Principal Investigator: Rabih Chaer, MD         
Sub-Investigator: Georges Al-Khoury, MD         
Sub-Investigator: Efthymios Avgerinos, MD         
Sub-Investigator: Steven Leers, MD         
Sub-Investigator: Eric Hager, MD         
Sub-Investigator: Bryan Tillman, MD         
Sub-Investigator: Michel Makaroun, MD         
Sub-Investigator: Michael Singh, MD         
Sub-Investigator: Raymond Eid, MD         
Sub-Investigator: Mohammad Eslami, MD         
Sub-Investigator: Michael Madigan, MD         
Sponsors and Collaborators
Rabih A. Chaer
Investigators
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Principal Investigator: Rabih A Chaer, MD University of Pittsburgh

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Responsible Party: Rabih A. Chaer, Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02758847     History of Changes
Other Study ID Numbers: PRO15120093
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: still early in the recruitment process

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Rabih A. Chaer, University of Pittsburgh:
critical lower limb ischemia with tissue loss

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action