FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study (MASCOT)
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|ClinicalTrials.gov Identifier: NCT00619788|
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : July 5, 2010
This investigation is designed to demonstrate the efficacy and safety of the 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use in a controlled clinical investigation.
The scoring balloon is a semi-compliant balloon encircled by 3 spiral struts with a nitinol scoring element, which theoretically provides targeted scoring of lesions, by concentrating the dilation force thus minimizing barotrauma, elastic recoil and uncontrolled dissection. This may improve the outcome of the intervention and reduce the number of stents required.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Occlusive Disease||Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicenter, Non-randomized Clinical Trial Investigating the Safety and Efficacy of the AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for the Treatment of Femoropopliteal Stenotic Disease.|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||October 2009|
Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use
Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter
The AngioSculpt Scoring Balloon Catheter is a line of innovative angioplasty catheters comprising an angioplasty balloon surrounded by a unique system of nitinol scoring elements. Creating focal concentrations of dilating force, the scoring elements score arterial lesions as the balloon expands.
- Complication Free Survival at 1 month post-procedure (complications = major amputations defined as amputations at or above the ankle, any cause of death and TLR) [ Time Frame: 1 month ]
- patency of the target lesion. Primary patency is defined as the absence of: a) target lesion revascularization (TLR); b) major amputation due to lesion restenosis or occlusion; c) conversion to bypass surgery and d) untreated significant stenosis on CFDU [ Time Frame: 12 months ]
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): NCT00619788
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|Leipzig, Germany, 04289|
|Principal Investigator:||Patrick Peeters, MD||Imelda Hospital, Bonheiden, Belgium|