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
Results First Received: April 4, 2014  
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
Condition: Critical Limb Ischemia
Intervention: Device: Endovascular peripheral intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
CLEARWAY GROUP 3 patients were randomized in this group.
ANGIOJET GROUP 3 patients were randomized in this group

Participant Flow:   Overall Study
    CLEARWAY GROUP     ANGIOJET GROUP  
STARTED     3     3  
COMPLETED     3     3  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CLEARWAY GROUP 3 patients were randomized in this group.
ANGIOJET GROUP 3 patients were randomized in this group
Total Total of all reporting groups

Baseline Measures
    CLEARWAY GROUP     ANGIOJET GROUP     Total  
Number of Participants  
[units: participants]
  3     3     6  
Age  
[units: years]
Mean ( Full Range )
  45  
  ( 42 to 49 )  
  63  
  ( 57 to 74 )  
  54  
  ( 42 to 74 )  
Gender  
[units: participants]
     
Female     2     1     3  
Male     1     2     3  
Diabetes  
[units: participants]
  2     1     3  
Hypertension  
[units: participants]
  2     2     4  
Dyslipidemia  
[units: participants]
  2     1     3  
Current smokers  
[units: participants]
  3     1     4  



  Outcome Measures
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1.  Primary:   Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence   [ Time Frame: 24 hours after the procedure ]

2.  Primary:   Incidence of Bleeding Complications   [ Time Frame: 24 hours after the procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The main limitation of this trial was slow enrollment. This led to early termination leading to small numbers of subjects analyzed. This makes the results uninterpretable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: J. Emilio Exaire MD
Organization: OUHSC
phone: 405 271 4742 ext 44744
e-mail: jose-exaire@ouhsc.edu


No publications provided


Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00869375     History of Changes
Other Study ID Numbers: CLEARWAY-CLI
Study First Received: March 25, 2009
Results First Received: April 4, 2014
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration