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Paclitaxel Eluting Balloon for SFA In-stent Restenosis

NCT ID: NCT01616888

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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In-stent Arterial Restenosis

Keywords

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drug eluting balloon with paclitaxel in stent restenosis femoropopliteal arteries angioplasty

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment arm

SFA angioplasty with In.Pact Admiral drug eluting balloon

Group Type ACTIVE_COMPARATOR

PTA with drug eluting balloon with paclitaxel

Intervention Type DEVICE

Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries

Interventions

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PTA with drug eluting balloon with paclitaxel

Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries

Intervention Type DEVICE

Other Intervention Names

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In.Pact Admiral by Medtronic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kong Teng Tan, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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KTT2

Identifier Type: -

Identifier Source: org_study_id