Back to resultsUse of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
Primary Purpose
Critical Limb Ischemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Endovascular peripheral intervention
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring acute or critical limb ischemia with angiographic thrombus
Eligibility 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)
Sites / Locations
- University of Oklahoma Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CLEARWAY GROUP
ANGIOJET GROUP
Arm Description
Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous in situ thrombolysis (local thrombolytic plus low pressure balloon angioplasty) with Clearway balloon
Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy with AngioJet Rheolytic Thrombectomy System
Outcomes
Primary Outcome Measures
Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence
Incidence of Bleeding Complications
Secondary Outcome Measures
Full Information
NCT ID
NCT00869375
First Posted
March 25, 2009
Last Updated
June 26, 2014
Sponsor
University of Oklahoma
Collaborators
Atrium Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00869375
Brief Title
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
Official Title
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
very low enrollment due to low access to study population
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Atrium Medical Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
acute or critical limb ischemia with angiographic thrombus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLEARWAY GROUP
Arm Type
Active Comparator
Arm Description
Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous in situ thrombolysis (local thrombolytic plus low pressure balloon angioplasty) with Clearway balloon
Arm Title
ANGIOJET GROUP
Arm Type
Active Comparator
Arm Description
Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy with AngioJet Rheolytic Thrombectomy System
Intervention Type
Device
Intervention Name(s)
Endovascular peripheral intervention
Other Intervention Name(s)
Clearway Balloon, AngioJet Rheolytic Thrombectomy System
Intervention Description
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
Primary Outcome Measure Information:
Title
Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence
Time Frame
24 hours after the procedure
Title
Incidence of Bleeding Complications
Time Frame
24 hours after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Emilio Exaire, MD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia
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