FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

Phase 2

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter

• Registration Number: NCT00619788
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-21
• Study Start: 2008-03
• Primary Completion: 2008-11
• Study Completion: 2009-10
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-02
• Last Update Posted: 2010-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	4.0-5.0mm AngioSculpt Scoring Balloon Catheter	Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use

Primary Outcome Measures

Name	Time	Method
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)	1 month

Secondary Outcome Measures

Name	Time	Method
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	12 months

Trial Locations

Locations (3)

AZ St-Blasius; 🇧🇪 Dendermonde, Belgium

Herzzentrum; 🇩🇪 Leipzig, Germany

Imelda Hospital; 🇧🇪 Bonheiden, Belgium