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Trial record 2 of 49 for:    PEARL II

Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01086215
First received: January 20, 2010
Last updated: November 3, 2014
Last verified: November 2014
Results First Received: October 29, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Peripheral Vascular Disease
Embolism and 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 (arterial, venous or hemodialysis access) procedure with the AngioJet Thrombectomy System were offered the opportuntity to participate. Patients were recruited from January 2010 thru June 2013.

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 presenting with limb ischemia for treatment
Deep Vein Thrombosis Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment

Participant Flow:   Overall Study
    Limb Ischemia     Deep Vein Thrombosis     Hemodialysis Access     Other Thrombotic Conditions  
STARTED     212     201     73     14  
3 Month Follow Up     201 [1]   187 [2]   64 [3]   13 [4]
6 Month Follow Up     192 [3]   172 [5]   60 [6]   12 [4]
12 Month Follow Up     176 [7]   154 [8]   47 [9]   11 [10]
COMPLETED     176     154     47     11  
NOT COMPLETED     36     47     26     3  
Death                 14                 8                 8                 1  
Lost to Follow-up                 22                 39                 18                 2  
[1] 7 LTF; 4 Deaths
[2] 10 LTF; 4 Deaths
[3] 5 LTF; 4 Deaths
[4] 1 LTF; 0 Deaths
[5] 13 LTF; 2 Deaths
[6] 4 LTF; 0 Deaths
[7] 10 LTF; 6 Deaths
[8] 16 LTF; 2 Deaths
[9] 9 LTF; 4 Deaths
[10] 0 LTF; 1 Death



  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.
Descriptive Analysis

Reporting Groups
  Description
Limb Ischemia Patients presenting with limb ischemia for treatment
Deep Vein Thrombosis Patients presenting with deep vein thrombosis for treatment
Hemodialysis Access Patients presenting with thrombosed hemodialysis access for treatment
Other Thrombotic Conditions Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
Total Total of all reporting groups

Baseline Measures
    Limb Ischemia     Deep Vein Thrombosis     Hemodialysis Access     Other Thrombotic Conditions     Total  
Number of Participants  
[units: participants]
  212     201     73     14     500  
Age  
[units: years]
Mean ± Standard Deviation
  63.6  ± 11.59     51.3  ± 16.37     61.6  ± 13.94     56.5  ± 12.07     58.1  ± 15.16  
Gender  
[units: participants]
         
Female     74     93     36     5     208  
Male     138     108     37     9     292  
Region of Enrollment  
[units: participants]
         
United States     154     190     73     13     430  
Slovakia     54     11     0     0     65  
Germany     1     0     0     1     2  
Italy     3     0     0     0     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Degree of Occlusion From Baseline to Final Angiogram/Venogram.   [ Time Frame: Day 1 ]

2.  Primary:   Rethrombosis   [ Time Frame: 3 Month , 6 Month and 12 Month Follow Up ]

3.  Secondary:   Concomitant Treatments Used With the AngioJet® System   [ Time Frame: Day 1 ]


  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
No text entered.


  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 more than 60 days but less than or equal to 180 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: Boston Scientific Corporation
phone: 763-450-8707
e-mail: deeann.tinjum@bsci.com


No publications provided


Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01086215     History of Changes
Other Study ID Numbers: PEARLII
Study First Received: January 20, 2010
Results First Received: October 29, 2014
Last Updated: November 3, 2014
Health Authority: United States: Institutional Review Board