Clinical trial NCT00619788: FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
Collaborators: name: AngioScore, Inc.
First posted: 2008-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 1 month
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ St-Blasius
city: Leipzig
country: Germany
facility: Herzzentrum
Study officials:
affiliation: Imelda Hospital, Bonheiden, Belgium
name: Patrick Peeters, MD
role: PRINCIPAL_INVESTIGATOR
References: