UnknownNot Applicable

Paclitaxel Eluting Balloon for SFA In-stent Restenosis

Canada30 participantsStarted 2012-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Target lesion patency at 6-month follow-up.

Timeframe: 6-month post index procedure

Trial details

NCT IDNCT01616888

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More In-stent Arterial Restenosis trials