FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study (MASCOT)

Flanders Medical Research Program

Status and phase

Completed

Phase 3

Phase 2

Conditions

Peripheral Arterial Occlusive Disease

Treatments

Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT00619788

FMRP-003

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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