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

This study has been terminated.
(very low enrollment due to low access to study population)
Sponsor:
Collaborator:
Atrium Medical Corporation
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00869375
First received: March 25, 2009
Last updated: June 26, 2014
Last verified: June 2014

March 25, 2009
June 26, 2014
April 2009
June 2012   (final data collection date for primary outcome measure)
  • Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence [ Time Frame: 24 hours after the procedure ] [ Designated as safety issue: No ]
  • Incidence of Bleeding Complications [ Time Frame: 24 hours after the procedure ] [ Designated as safety issue: Yes ]
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00869375 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Critical Limb Ischemia
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
Other Names:
  • Clearway Balloon
  • AngioJet Rheolytic Thrombectomy System
  • Active Comparator: CLEARWAY GROUP
    Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous in situ thrombolysis (local thrombolytic plus low pressure balloon angioplasty) with Clearway balloon
    Intervention: Device: Endovascular peripheral intervention
  • Active Comparator: ANGIOJET GROUP
    Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy with AngioJet Rheolytic Thrombectomy System
    Intervention: Device: Endovascular peripheral intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2012
June 2012   (final data collection date for primary outcome measure)

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)

Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00869375
CLEARWAY-CLI
Yes
University of Oklahoma
University of Oklahoma
Atrium Medical Corporation
Principal Investigator: J. Emilio Exaire, MD University of Oklahoma
University of Oklahoma
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP