department of neurology  
  Telephone: 212 305-1710 || Address: The Neurological Insitute of New York, 710 West 168th Street, 6th Floor, New York, NY 10032  
 
 
 

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




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Objective:

The primary objective of the study is to determine whether intracranial angioplasty plus stenting with intensive medical therapy is superior to intensive medical therapy alone for preventing any stroke or death within 30 days after study entry or ischemic stroke in the territory of the symptomatic intracranial artery from day 31 to close-out (mean follow-up of 2 years) in patients with 70% - 99% stenosis of a major intracranial artery (MCA, carotid, vertebral, basilar) and TIA or non-disabling stroke within 30 days prior to enrollment.

Study Design:

This is an investigator-initiated, multi-center, randomized, phase III clinical trial.

Study Duration:

5 years

Study Population:

764 participants with symptomatic intracranial stenosis

Clinical Sites:

Up to 50 actively enrolling sites in the USA

Primary Endpoints:

Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 to the end of follow-up (mean follow-up expected to be 2 years).

Secondary Endpoints:

Clinical Secondary Endpoints

  1. Ischemic stroke outside of the territory of the symptomatic artery beyond 30 days after enrollment

  2. any parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage beyond 30 days after enrollment

  3. myocardial infarction

  4. major non-stroke hemorrhage (i.e., any subdural hemorrhage, any epidural hemorrhage, major systemic hemorrhage)

  5. any death beyond 30 days after enrollment

  6. disabling stroke

  7. any serious adverse event (see page 27)

  8. target lesion revascularization.

Technical Secondary Endpoints:

  1. Balloon success

  2. Stent success

  3. Procedural success
See section 8 for definitions of these technical endpoints.

Investigational Device Name:

Wingspan Stent® System and Gateway™ PTA Balloon Catheter (manufactured by Boston Scientific Corporation)

Intended Use:

For improving luminal diameter in participants with symptomatic stenosis of a major intracranial artery with target lesions up to 14 mm long and with reference vessel diameters of 2.00 - 4.5 mm.

Sponsor:


Investigator initiated, NIH funded trial
P.I.: Marc I. Chimowitz MBChB
Professor of Neurology
Medical University of South Carolina
Charleston, SC

CUMC Principal Investigator:


Mitchell Elkind, MD, MS
Neurological Institute Box 182
710 West 168th Street
New York, NY 10032
Tel: 212 305-1710

CUMC Coordinator:


Tania Corporan
Neurological Institute
710 West 168th Street
New York, NY 10032
Tel: 212 305-7755

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Copyright © 2008 Division of Stroke, Department of Neurology, Columbia University Medical Center, New York || The Neurological Institute of New York || Affiliated with New York-Presbyterian Hospital || Last updated: February 23, 2010 | Comments