Paclitaxel Eluting Balloon for SFA In-stent Restenosis

University Health Network, Toronto

Status: Unknown

Conditions: In-stent Arterial Restenosis

Treatments: Device: PTA with drug eluting balloon with paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01616888

KTT2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment arm

Active Comparator group

Description:

SFA angioplasty with In.Pact Admiral drug eluting balloon

Treatment:

Device: PTA with drug eluting balloon with paclitaxel