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Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia

NCT00869375 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-07-21

Study results available
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Summary

The purpose of this study is to compare the effects (positive and negative) of two different devices available to treat people with critical limb ischemia, which involves a sudden decrease in blood flow to the leg that causes a potential threat to the limb and causes pain at rest, ulcers or gangrene.

One device is the Clearway balloon, which delivers a drug to dissolve the clot where the blockage is. The other device is the Angiojet, which removes the clot in a mechanical way ("vacuum" effect). This research is being done because currently there is no single proven effective treatment for this condition. Even though, both these devices are commonly used in the clinical practice to treat critical limb ischemia, there are no studies that compare these devices and help us see which one may be better for these patients.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

Endovascular peripheral intervention

Clearway Balloon: percutaneous transluminal angioplasty with simultaneous in situ thrombolysis using the Clearway balloon AngioJet Rheolytic Thrombectomy System: percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy using the Angiojet

Sponsors & Collaborators

  • Atrium Medical Corporation

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • J. Emilio Exaire, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

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 NCT00869375 on ClinicalTrials.gov