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Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576693
First Posted: December 19, 2007
Last Update Posted: July 11, 2014
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.
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Marc Chimowitz, Medical University of South Carolina
Results First Submitted: May 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Device: intracranial angioplasty and stenting
Other: intensive medical management

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intensive Medical Management Plus Stenting

intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).

intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia

Intensive Medical Management Alone

Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)

intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)


Participant Flow:   Overall Study
    Intensive Medical Management Plus Stenting   Intensive Medical Management Alone
STARTED   224   227 
COMPLETED   214   203 
NOT COMPLETED   10   24 
Lost to Follow-up                7                11 
Withdrawal by Subject                3                13 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment.   [ Time Frame: Mean length of follow-up was 2.4 years ]


  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 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: Marc I. Chimowitz, MBChB
Organization: Medical University of South Carolina
phone: 843-792-3020
e-mail: mchimow@musc.edu


Publications of Results:

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


Responsible Party: Marc Chimowitz, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00576693     History of Changes
Other Study ID Numbers: R01NS058728-01A1
NINDS ( Other Identifier: NINDS )
CRC ( Other Identifier: NINDS )
1U01NS058728-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2007
First Posted: December 19, 2007
Results First Submitted: May 6, 2014
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014