Paclitaxel Eluting Balloon for SFA In-stent Restenosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01616888|
Recruitment Status : Unknown
Verified December 2014 by University Health Network, Toronto.
Recruitment status was: Active, not recruiting
First Posted : June 12, 2012
Last Update Posted : December 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|In-stent Arterial Restenosis||Device: PTA with drug eluting balloon with paclitaxel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||August 2015|
Active Comparator: Treatment arm
SFA angioplasty with In.Pact Admiral drug eluting balloon
Device: PTA with drug eluting balloon with paclitaxel
Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries
Other Name: In.Pact Admiral by Medtronic
- Target lesion patency at 6-month follow-up. [ Time Frame: 6-month post index procedure ]Patency of target lesion at 6-month follow-up based on duplex ultrasound.
- Clinical success up to 12 months post index procedure [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616888
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Kong Teng Tan, MD||University Health Network, Toronto|