FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study - Full Text View

Sponsors and Collaborators:	Flanders Medical Research Program AngioScore, Inc.
Information provided by:	Flanders Medical Research Program
ClinicalTrials.gov Identifier:	NCT00619788

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Occlusive Disease	Device: 4.0-5.0mm AngioSculpt Scoring Balloon Catheter	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

Further study details as provided by Flanders Medical Research Program:

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) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients receiving 4.0-5.0mm AngioSculpt Scoring Balloon Catheter (AngioScore, Inc.) for femoropopliteal use	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.

Detailed Description:

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619788

Contacts

Contact: Patrick Peeters, MD	+3215506197	patrick.peeters@imelda.be
Contact: Koen De Meester	+3252252822	koen.demeester@fmrp.be

Locations

Belgium
Imelda Hospital	Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters, MD +3215506197 patrick.peeters@imelda.be
Contact: Erwin Vinck +32474994527 erwin.vinck@fmrp.be
Principal Investigator: Patrick Peeters, MD
AZ St-Blasius	Recruiting
Dendermonde, Belgium, 9200
Contact: Marc Bosiers, MD +3252252822 marc.bosiers@telenet.be
Contact: Koen De Meester +3252252822 koen.demeester@fmrp.be
Principal Investigator: Marc Bosiers, MD
Sub-Investigator: Koen Deloose, MD
Germany
Herzzentrum	Not yet recruiting
Leipzig, Germany, 04289
Contact: Dierk Schneinert, MD +49 3418651740 dierk.scheinert@gmx.de
Principal Investigator: Dierk Scheinert, MD

Sponsors and Collaborators

Flanders Medical Research Program

AngioScore, Inc.

Investigators

Principal Investigator:

Patrick Peeters, MD

Imelda Hospital, Bonheiden, Belgium

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Flanders Medical Research Program ( Flanders Medical Research Program )
Study ID Numbers:	FMRP-003
Study First Received:	February 7, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00619788
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009