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FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

NCT00619788 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-07-05

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Occlusive Disease

Interventions

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.

Sponsors & Collaborators

  • AngioScore, Inc.

    collaborator INDUSTRY

  • Flanders Medical Research Program

    lead NETWORK

Principal Investigators

  • Patrick Peeters, MD · Imelda Hospital, Bonheiden, Belgium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-11-30
Completion
2009-10-31

Countries

  • Belgium
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00619788 on ClinicalTrials.gov