FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

Peripheral Arterial Occlusive Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619788
• Other study ID #: FMRP-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 7, 2008
• Last updated: July 2, 2010
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: July 2010
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

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.

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ St-Blasius	Dendermonde
Germany	Herzzentrum	Leipzig

Sponsors (2)

Lead Sponsor	Collaborator
Flanders Medical Research Program	AngioScore, Inc.

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

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