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FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study (MASCOT)

Primary Purpose

Peripheral Arterial Occlusive Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
4.0-5.0mm AngioSculpt Scoring Balloon Catheter
Sponsored by
Flanders Medical Research Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imelda Hospital
  • AZ St-Blasius
  • Herzzentrum

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2008
Last Updated
July 2, 2010
Sponsor
Flanders Medical Research Program
Collaborators
AngioScore, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00619788
Brief Title
FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study
Acronym
MASCOT
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Flanders Medical Research Program
Collaborators
AngioScore, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use
Intervention Type
Device
Intervention Name(s)
4.0-5.0mm AngioSculpt Scoring Balloon Catheter
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Peeters, MD
Organizational Affiliation
Imelda Hospital, Bonheiden, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
Herzzentrum
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.fmrp.be
Description
Related Info

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FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

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