Paclitaxel Eluting Balloon for SFA In-stent Restenosis

In-stent Arterial Restenosis Clinical Trial

Official title:

Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01616888
• Other study ID #: KTT2
• Status: Active, not recruiting
• Phase: N/A
• First received: June 7, 2012
• Last updated: December 5, 2014
• Start date: June 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-stent Arterial Restenosis

Intervention

Device:
• PTA with drug eluting balloon with paclitaxel
Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion patency at 6-month follow-up.	Patency of target lesion at 6-month follow-up based on duplex ultrasound.	6-month post index procedure	No
Secondary	Clinical success up to 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.	12 months post index procedure	No