Status:
COMPLETED
FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study
Lead Sponsor:
Flanders Medical Research Program
Collaborating Sponsors:
AngioScore, Inc.
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 investig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00619788
Start Date
March 1 2008
End Date
October 1 2009
Last Update
July 5 2010
Active Locations (3)
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1
Imelda Hospital
Bonheiden, Belgium, 2820
2
AZ St-Blasius
Dendermonde, Belgium, 9200
3
Herzzentrum
Leipzig, Germany, 04289