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Paclitaxel Eluting Balloon for SFA In-stent Restenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01616888
Recruitment Status : Unknown
Verified December 2014 by University Health Network, Toronto.
Recruitment status was:  Active, not recruiting
First Posted : June 12, 2012
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
In-stent Arterial Restenosis Device: PTA with drug eluting balloon with paclitaxel

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries
Study Start Date : June 2012
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

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 Name: In.Pact Admiral by Medtronic


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01616888


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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01616888     History of Changes
Other Study ID Numbers: KTT2
First Posted: June 12, 2012    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014

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

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