NCT00869375

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

Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia: A Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This prospective randomized clinical trial in patients with peripheral vascular disease and acute or subacute arterial thrombosis will compare percutaneous transluminal angioplasty and simultaneous in situ thrombolysis using the Clearway balloon system with mechanical thrombectomy with the Angiojet system. Main endpoints are the time to successful revascularization, the frequency of distal embolization and the incidence of bleeding complications.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-03-26
• Last updated: 2014-07-21
• Results posted: 2014-07-21

Locations

1 site across 1 country: United States