Paclitaxel Eluting Balloon for SFA In-stent Restenosis

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: June 7, 2012
Last updated: December 5, 2014
Last verified: December 2014

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.

Condition Intervention
In-stent Arterial Restenosis
Device: PTA with drug eluting balloon with paclitaxel

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries

Resource links provided by NLM:

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Target lesion patency at 6-month follow-up. [ Time Frame: 6-month post index procedure ] [ Designated as safety issue: No ]
    Patency of target lesion at 6-month follow-up based on duplex ultrasound.

Secondary Outcome Measures:
  • Clinical success up to 12 months post index procedure [ Time Frame: 12 months post index procedure ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: In.Pact Admiral by Medtronic

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01616888

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Kong Teng Tan, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto Identifier: NCT01616888     History of Changes
Other Study ID Numbers: KTT2
Study First Received: June 7, 2012
Last Updated: December 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
drug eluting balloon with paclitaxel
in stent restenosis
femoropopliteal arteries

Additional relevant MeSH terms:
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on October 02, 2015