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

This study has been completed.
Sponsor:
Collaborator:
Atrium Medical Corporation
Information provided by (Responsible Party):
Jose Exaire, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00869375
First received: March 25, 2009
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Critical Limb Ischemia
 Device: endovascular peripheral intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia: A Randomized Controlled Trial

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • time to successful revascularization (defined as less than 50% residual stenosis and brisk antegrade flow) [ Time Frame: at the end of procedure ] [ Designated as safety issue: No ]
  • Immediate distal embolization detected by angiographic and/or clinical evidence [ Time Frame: during or at the end of procedure ] [ Designated as safety issue: No ]
  • incidence of bleeding complications [ Time Frame: within 24 hours after procedure and prior to hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amputation rate [ Time Frame: 30 days after procedure ] [ Designated as safety issue: No ]
  • Vascular ultrasound patency [ Time Frame: 30 days after procedure ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 30 days after procedure ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: April 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CLEARWAY GROUP
Local thrombolytic plus low pressure balloon angioplasty with Clearway balloon
 Device: endovascular peripheral intervention
percutaneous transluminal angioplasty with simultaneous in situ thrombolysis using the Clearway balloon or mechanical thrombectomy using the Angiojet
Active Comparator: ANGIOJET GROUP
Mechanical thrombectomy with AngioJet Rheolytic Thrombectomy System
 Device: endovascular peripheral intervention
percutaneous transluminal angioplasty with simultaneous in situ thrombolysis using the Clearway balloon or mechanical thrombectomy using the Angiojet

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869375

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Atrium Medical Corporation
Investigators
Principal Investigator: J. Emilio Exaire, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: Jose Exaire, Assistant Professor, University of Oklahoma
ClinicalTrials.gov Identifier: NCT00869375     History of Changes
Other Study ID Numbers: CLEARWAY-CLI
Study First Received: March 25, 2009
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Oklahoma:
acute or critical limb ischemia with angiographic thrombus

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013