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SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study (SWIFT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01054560
First Posted: January 22, 2010
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
Results First Submitted: April 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Device: SOLITAIRE™ Device
Device: MERCI® Device

  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
Subject enrolled from Feb 2010 to Feb 2011. Subject randomized to Solitaire or Merci by baseline National Institutes of Health Stroke Scale Score.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study had Roll-in period. Participating centers in the United States were required to enroll two (2) roll-in subjects prior to the subject randomization. There were a total of 31 roll-in subjects. Only data from the randomized cohort was used for both primary efficacy analysis and the safety endpoint analysis.

Reporting Groups
  Description
SOLITAIRE™ Device The SOLITAIRE™ Device (investigational device) is the experimental arm
MERCI® Device The MERCI® Device (control device) is commercially available.

Participant Flow:   Overall Study
    SOLITAIRE™ Device   MERCI® Device
STARTED   58   55 
COMPLETED   45   27 
NOT COMPLETED   13   28 
Death                10                21 
Lost to Follow-up                2                5 
Withdrawal by Subject                0                2 
Physician Decision                1                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
SOLITAIRE™ Device The SOLITAIRE™ Device (investigational device) is the experimental arm
MERCI® Device The MERCI® Device (control device) is commercially available.
Total Total of all reporting groups

Baseline Measures
   SOLITAIRE™ Device   MERCI® Device   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   55   113 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   22   22   44 
>=65 years   36   33   69 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.1  (12.0)   67.1  (11.1)   67.1  (11.5) 
Gender 
[Units: Participants]
     
Female   30   27   57 
Male   28   28   56 
Region of Enrollment 
[Units: Participants]
     
United States   57   54   111 
Europe   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Recanalization [Thrombolysis in Myocardial Infarction (TIMI) 2 or 3] Without Symptomatic Intracranial Hemorrhage   [ Time Frame: Immediately post treatment ]

2.  Primary:   Study Device-related Serious Adverse Events (SAEs)   [ Time Frame: 90 Day ]

3.  Primary:   Procedure-related Serious Adverse Events (SAEs)   [ Time Frame: 90 Day ]

4.  Secondary:   Time to Initial Recanalization   [ Time Frame: post treatment ]

5.  Secondary:   Good Neurological Outcome at 30 Days   [ Time Frame: 30 Days Follow-up ]

6.  Secondary:   Good Neurological Outcome 90 Days   [ Time Frame: 90 Days Follow-up ]

7.  Secondary:   Mortality   [ Time Frame: 90 Days follow-up ]

8.  Secondary:   Symptomatic Intracranial Hemorrhage   [ Time Frame: 24 hours ]

9.  Secondary:   Non-fatal Stroke-related Morbidity   [ Time Frame: 90 Day ]


  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
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  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 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.


Results Point of Contact:  
Name/Title: Director of Clinical Affairs
Organization: Covidien
phone: 9498373700


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01054560     History of Changes
Other Study ID Numbers: SWIFT
First Submitted: December 10, 2009
First Posted: January 22, 2010
Results First Submitted: April 24, 2012
Results First Posted: October 26, 2016
Last Update Posted: October 26, 2016