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FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study (MASCOT)

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: NCT00619788
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : July 5, 2010
Sponsor:
Collaborator:
AngioScore, Inc.
Information provided by:
Flanders Medical Research Program

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: 1
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - SFA)
  • Length of lesion >5 cm or 2 times the AngioSculpt balloon length (whichever is longer)
  • Reference vessel diameter should be 4.0-6.0 mm
  • Life altering claudication or critical limb ischemia (Rutherford 3-5)
  • No untreated inflow-limiting arterial lesions
  • At least single vessel run-off until the ankle
  • The patient must be > 18 years.
  • Life-expectancy of more than 12 months
  • The subject or legal guardian has been informed of the nature of the evaluation; agrees to its provisions and has signed informed consent
  • The patient is capable to follow all evaluation requirements.

Exclusion Criteria:

  • Patient refusing treatment
  • The reference segment diameter is not suitable for available catheter design
  • Length of lesion is ≥5 cm or requires more than two overlapping AngioSculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length)
  • The patient has a known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies
  • The patient has a history of prior life-threatening contrast media reaction
  • The patient is currently enrolled in another investigational device or drug trial
  • The patient is currently breast-feeding, pregnant or intends to become pregnant

Information from the National Library of Medicine

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


Locations
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Belgium
Imelda Hospital
Bonheiden, Belgium, 2820
AZ St-Blasius
Dendermonde, Belgium, 9200
Germany
Herzzentrum
Leipzig, Germany, 04289
Sponsors and Collaborators
Flanders Medical Research Program
AngioScore, Inc.
Investigators
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Principal Investigator: Patrick Peeters, MD Imelda Hospital, Bonheiden, Belgium

Additional Information:
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Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT00619788    
Other Study ID Numbers: FMRP-003
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: July 5, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases