Paclitaxel Eluting Balloon for SFA In-stent Restenosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01616888
First received: June 7, 2012
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

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)
Intervention Details:
    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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616888

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Iris Zhong    (416) 946-4501 ext 4816    iris.zhong@uhn.ca   
Principal Investigator: Kong Teng Tan, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Kong Teng Tan, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01616888     History of Changes
Other Study ID Numbers: KTT2
Study First Received: June 7, 2012
Last Updated: June 8, 2012
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014