FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

NCT ID: NCT00619788

Last Updated: 2010-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-10-31

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.

Conditions

Peripheral Arterial Occlusive Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: EXPERIMENTAL

4.0-5.0mm AngioSculpt Scoring Balloon Catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AngioScore, Inc.

INDUSTRY

Sponsor Role: collaborator

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Flanders Medical Research Program

Principal Investigators

Patrick Peeters, MD

Role: PRINCIPAL_INVESTIGATOR

Imelda Hospital, Bonheiden, Belgium

Locations

Imelda Hospital

Bonheiden, , Belgium

AZ St-Blasius

Dendermonde, , Belgium

Herzzentrum

Leipzig, , Germany

Countries

Belgium; Germany

Other Identifiers

FMRP-003

Identifier Type: -

Identifier Source: org_study_id