Paclitaxel Eluting Balloon for SFA In-stent Restenosis

Not Applicable

• Conditions: In-stent Arterial Restenosis
• Interventions: Device: PTA with drug eluting balloon with paclitaxel

• Registration Number: NCT01616888
• Lead Sponsor: University Health Network, Toronto

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.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-09
• Primary Completion: 2015-06
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	PTA with drug eluting balloon with paclitaxel	SFA angioplasty with In.Pact Admiral drug eluting balloon

Primary Outcome Measures

Name	Time	Method
Target lesion patency at 6-month follow-up.	6-month post index procedure	Patency of target lesion at 6-month follow-up based on duplex ultrasound.

Secondary Outcome Measures

Name	Time	Method
Clinical success up to 12 months post index procedure	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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada