We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial (SWIFT PRIME)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01657461
First Posted: August 6, 2012
Last Update Posted: May 18, 2017
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: November 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Acute Ischemic Stroke
Interventions: Drug: Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
Device: Solitaire revascularization device

  Participant Flow
  Hide Participant Flow

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
IV t-PA With Solitaire™ Revascularization Device Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV t-PA IV infusion of tPA

Participant Flow:   Overall Study
    IV t-PA With Solitaire™ Revascularization Device   IV t-PA
STARTED   98   98 
COMPLETED   88   78 
NOT COMPLETED   10   20 
Death                9                12 
Lost to Follow-up                0                3 
Physician Decision                0                2 
Withdrawal by Subject                1                3 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Two subjects in the IV t-PA arm withdrew and requested all data removed and was not included in analysis.

Reporting Groups
  Description
IV t-PA With Solitaire™ Revascularization Device Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
IV t-PA IV infusion of tPA
Total Total of all reporting groups

Baseline Measures
   IV t-PA With Solitaire™ Revascularization Device   IV t-PA   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   96   194 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 98   95   193 
   64.99  (12.49)   66.32  (11.277)   65.64  (11.89) 
[1] Date of birth was not recorded per country regulations.
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 98   96   194 
Female      44  44.9%      51  53.1%      95  49.0% 
Male      54  55.1%      45  46.9%      99  51.0% 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed 
[Units: Participants]
 98   96   194 
United States   65   66   131 
Austria       
Participants Analyzed 
[Units: Participants]
 98   96   194 
Austria   1   1   2 
Denmark       
Participants Analyzed 
[Units: Participants]
 98   96   194 
Denmark   1   1   2 
France       
Participants Analyzed 
[Units: Participants]
 98   96   194 
France   8   4   12 
Germany       
Participants Analyzed 
[Units: Participants]
 98   96   194 
Germany   20   22   42 
Spain       
Participants Analyzed 
[Units: Participants]
 98   96   194 
Spain   1   1   2 
Switzerland       
Participants Analyzed 
[Units: Participants]
 98   96   194 
Switzerland   2   1   3 
NIHSS [1] [2] 
[Units: Scores on a scale]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 98   94   192 
   16.69  (4.68)   16.49  (4.60)   16.59  (4.63) 
[1] The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. NIHSS scores range from 0 – 42. A score of 0 indicates no stroke symptoms. Higher scores indicate incremental levels of neurological impairment.
[2] Two subjects in the IV t-PA arm did not have baseline NIHSS recorded


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS).   [ Time Frame: 90 days ]

2.  Secondary:   Death Due to Any Cause at 90 Days   [ Time Frame: 90 days ]

3.  Secondary:   Functional Independence as Defined by Modified Rankin Scale (mRS) Score ≤2 at 90 Days   [ Time Frame: 90 days ]

4.  Secondary:   Change in NIH Stroke Scale Score at 27 ± 6 Hrs Post Randomization   [ Time Frame: Baseline to 27±6 hours post randomization ]

5.  Secondary:   Volume of Cerebral Infarction as Measured by a CT or MRI Scan at 27±6 Hours Post Randomization   [ Time Frame: 27±6 hours post randomization ]

6.  Secondary:   Reperfusion Measured by Reperfusion Ratio on CT or MRI Scan 27±6 Hours Post Randomization   [ Time Frame: 27±6 hours post randomization ]

7.  Secondary:   Arterial Revascularization Measured by TICI 2b or 3 Following Device Use   [ Time Frame: Post procedure ]

8.  Secondary:   Correlation of RAPID-assessed Core Infarct Volume With 27±6 Hours Post Randomization Stroke Infarction in Subjects Who Achieved TICI 2b-3 Reperfusion Without Intracranial Hemorrhage   [ Time Frame: 27±6 hours post randomization ]

9.  Other Pre-specified:   Incidence of All Serious Adverse Events (SAEs)   [ Time Frame: Through 90 days ]

10.  Other Pre-specified:   Incidence of sICH at 27±6 Hours Post Randomization   [ Time Frame: 27±6 hours post randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: Manish Gupta, Sr. Director of Medical Affairs
Organization: Medtronic
phone: 949 297 5494
e-mail: manish.s.gupta@medtronic.com


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

Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01657461     History of Changes
Other Study ID Numbers: NV-SFR004
First Submitted: August 2, 2012
First Posted: August 6, 2012
Results First Submitted: November 15, 2016
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017