Status:
TERMINATED
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
Atrium Medical Corporation
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 fl...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00869375
Start Date
April 1 2009
End Date
June 1 2012
Last Update
July 21 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104