Paclitaxel Eluting Balloon for SFA In-stent Restenosis

December 5, 2014 updated by: University Health Network, Toronto

Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries

The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5
  • in-stent restenosis or occlusion in SFA or PPA 20mm - 200mm

Exclusion Criteria:

  • participation in another investigational drug or device trial
  • life expectancy less than 12 months
  • acute ischemia and/or acute thrombosis of the SFA/PPA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment arm
SFA angioplasty with In.Pact Admiral drug eluting balloon
Device: PTA with drug eluting balloon with paclitaxel
Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries
Other Names:
  • In.Pact Admiral by Medtronic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion patency at 6-month follow-up.
Time Frame: 6-month post index procedure
Patency of target lesion at 6-month follow-up based on duplex ultrasound.
6-month post index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success up to 12 months post index procedure
Time Frame: 12 months post index procedure
Improvement on clinical evaluations including staging of PAD according to the Rutherford category, ABI at 1, 6, 12 months post procedure compared to baseline assessment.
12 months post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 12, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KTT2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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