Use of Clearwayâ„¢ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
| Status: | Archived |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2009 |
| End Date: | January 2012 |
Use of Clearwayâ„¢ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia: A Randomized Controlled Trial
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.
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.
We found this trial at
1
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