A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT00778336
First received: October 22, 2008
Last updated: July 9, 2012
Last verified: July 2012
Results First Received: February 22, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Peripheral Vascular Diseases
Thrombosis
Venous Thrombosis

  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
Patients presenting at a participating site who were clinically indicated for a peripheral interventional(venous or arterial) procedure with the mid-length (90cm or 120cm catheters) catheter were offered the opportunity to participate. Patients were recruited from January 2007 thru December 2009.

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
Limb Ischemia Patients with limb ischemia treated with a midlength AngioJet catheter.
Deep Vein Thrombosis Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
Hemodialysis Access Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
Other Thrombotic Conditions Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.

Participant Flow for 2 periods

Period 1:   Index Procedure-Discharge
    Limb Ischemia     Deep Vein Thrombosis     Hemodialysis Access     Other Thrombotic Conditions  
STARTED     198     170     72     12  
COMPLETED     192     167     70     12  
NOT COMPLETED     6     3     2     0  
Death                 6                 3                 2                 0  

Period 2:   3 Month Follow Up
    Limb Ischemia     Deep Vein Thrombosis     Hemodialysis Access     Other Thrombotic Conditions  
STARTED     192     167     70     12  
COMPLETED     169     144     65     12  
NOT COMPLETED     23     23     5     0  
Lost to Follow-up                 15                 20                 3                 0  
Death                 8                 3                 2                 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
Limb Ischemia Patients with limb ischemia treated with a midlength AngioJet catheter.
Deep Vein Thrombosis Patients with deep vein thrombosis treated with a midlength AngioJet catheter.
Hemodialysis Access Patients with thrombosed hemodialysis access treated with a midlength AngioJet catheter.
Other Thrombotic Conditions Patients with a thrombotic Condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access treated with a midlength AngioJet catheter.
Total Total of all reporting groups

Baseline Measures
    Limb Ischemia     Deep Vein Thrombosis     Hemodialysis Access     Other Thrombotic Conditions     Total  
Number of Participants  
[units: participants]
  198     170     72     12     452  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± 14     52  ± 17     63  ± 13     63  ± 18     61  ± 16  
Gender  
[units: participants]
         
Female     88     64     34     6     192  
Male     110     106     38     6     260  
Region of Enrollment  
[units: participants]
         
United States     198     170     72     12     452  



  Outcome Measures
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1.  Primary:   Change From Baseline to Final Angiographic Results   [ Time Frame: Index Procedure ( pre-endovascular treatment and post-endovascular treatment) ]

2.  Secondary:   Rethrombosis   [ Time Frame: 3 Month Follow Up ]

3.  Secondary:   Description of Treatments by Thrombotic Condition   [ Time Frame: Index 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
Non randomized observational registry


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DeeAnn Tinjum
Organization: MEDRAD Interventional / Possis
phone: 763-450-8707
e-mail: deeann.tinjum@possis.com


No publications provided


Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT00778336     History of Changes
Other Study ID Numbers: PEARL
Study First Received: October 22, 2008
Results First Received: February 22, 2011
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board