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

Stopped early · Not applicable

Conditions studied: Critical Limb Ischemia

In brief

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.

Key facts

Study ID

NCT00869375

Run by

University of Oklahoma

People needed

6

Starts

2009-04-01

Expected to finish

2012-06-01

Last updated by the study team

2014-07-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults between 18 and 85 years of age
• Diagnosis of acute limb ischemia (defined as an abrupt onset of lower extremity pain with loss of peripheral pulses and absent Doppler pulses in at least one artery and/or ultrasonographic evidence of decreased or absent blood flow to the affected limb) or Diagnosis of critical limb ischemia (defined as resting lower extremity pain with an ABI of <0.4 and/or ultrasonographic evidence of decreased or absent blood flow to the affected limb).
• Angiographic confirmation of thrombus.
• Need of an intervention within 21 days of the onset of symptoms

You may not qualify if…

• Any contraindication for thrombolytic therapy
• ABSOLUTE CONTRAINDICATIONS:
• A. Any history of intracranial hemorrhage; recent (within three months) hemorrhagic cerebrovascular accident (CVA) / transient ischemic attack (TIA) or significant closed head or facial injury.
• B. Known intracranial neoplasm or arteriovenous malformation. C. Suspected aortic dissection. D. Active bleeding diathesis or hemostatic defects: (Excluding menses); active internal
• RELATIVE CONTRAINDICATIONS:
• Fibrinolytic therapy may be used with the presence of these conditions upon clinical assessment or treatment dependent upon bleeding risks:
• A. History of chronic, severe, and poorly controlled blood pressure or Severe uncontrolled hypertension on presentation (SBP >180, DBP >110).
• B. History of prior ischemic stroke (greater than 3 months) dementia, or known intracranial pathology not covered in absolute contraindications.
• C. Traumatic or prolonged CPR (> 10 minutes), major surgery (< 3 weeks), or recent trauma, including head trauma (2-4 weeks).
• D. Recent (within 2 to 4 weeks) internal bleeding. E. Noncompressible vascular punctures. F. Pregnancy or recent obstetrical delivery. G. Active peptic ulcer disease. H. Anticoagulant use (INR > 2-3)

Where it is running

• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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