POSITIVE Stroke Clinical Trial

Description

The primary objective of this randomized trial is to determine the safety and efficacy of intra-arterial reperfusion in Acute Ischemic Stroke (AIS) patients ineligible for IV-tPA as selected by physiologic imaging criteria.

Study Start Date

September 2013

Estimated Completion Date

May 2016

Interventions

  • Device: Endovascular Mechanical Thrombectomy

Specialties

  • Neurology: Stroke/Vascular

MeSH Terms

  • Endovascular Mechanical Thrombectomy
  • Stroke
  • intra-arterial reperfusion

Study ID

Medical University of South Carolina -- PRO23329

Status

Unknown

Trial ID

NCT01852201

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

750

Sponsor

Medical University of South Carolina

Inclusion Criteria

    1. Age 18 to 80 years (i.e., candidates must have had their 18th birthday, but not had their 81st birthday). 2. NIHSS ?8 at the time of neuroimaging 3. Presenting or persistent symptoms within 12 hours of when groin puncture can be obtained 4. Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA M1 bifurcation). 5. The operator feels that the stroke can be appropriately treated with traditional endovascular techniques (endovascular thrombectomy without adjunctive devices such as stents). 6. Pre-event Modified Rankin Scale score 0-1 7. Consenting requirements met according to local IRB

Exclusion Criteria

    1. Pt eligible for IV-tPA therapy. 2. Rapidly improving neurologic examination. 3. Absence of large vessel occlusion on non-invasive imaging. 4. Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory 5. Absence of an associated large penumbra as defined by physiologic imaging according to standard of practice at the participating institution 6. Subarachnoid hemorrhage in the past 60 days 7. Any intracranial hemorrhage in the last 90 days 8. Known irreversible bleeding disorder 9. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency or oral anticoagulant therapy with INR > 2.5 or institutionally equivalent prothrombin time of 2.5 times normal. 10. Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction 11. Inability to tolerate, clinically documented evidence in medical history of adverse reaction or contraindication to medications used in treatment of the stroke 12. Contraindication to CT and MRI (ie. Iodine contrast allergy, or other condition that prohibits imaging from either CT or MRI) 13. Known allergy to contrast used in angiography that cannot be medically controlled 14. Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL) 15. Pregnancy, breast-feeding, or positive pregnancy test [either serum or urine] (Woman of child-bearing potential must have a negative pregnancy test prior to the study procedure.) 16. Evidence of active infection [indicated by fever (at or over 99.9 °F) and/or open draining wound] at the time of randomization 17. Current use of cocaine or other vasoactive substance 18. Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days. 19. Based on investigator's judgment, patient does not have the necessary mental capacity to participate or is unwilling or unable to comply with protocol follow up appointment schedule. 20. Currently participating in another interventional (drug, device, etc) research project Head CT or MRI Scan Exclusion Criteria
  • Presence of blood on imaging (SAH, ICH, etc).
  • High density lesion consistent with hemorrhage of any degree.
  • Significant mass effect with midline shift.
  • Large (more than 1/3 of the middle cerebral artery) regions of clear hypodensity on the baseline CT scan or ASPECTS of < 7. Sulcal effacement and / or loss of grey-white differentiation alone are not contraindications for treatment.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (13)

Study Location Distance Name Phone Email
Stony Brook Medical Center - Stony Brook, New York 23.2 miles David Fiorella None None
Captial Health - Trenton, New Jersey 101.2 miles Erol Veznedaroglu MD None None
Univesity of MassachusettsWorcester - Worcester, Massachusetts 106.5 miles Ajit Puri MD None None
University of Buffalo Neurosurgery - Buffalo, New York 311.0 miles Adnan Siddiqui MD None None
West Virginia University - Morgantown, West Virginia 371.3 miles Ansaar Rai MD None None
Cleveland Clinic - Cleveland, Ohio 435.4 miles Gabor Toth MD None None
Ohio Health - Columbus, Ohio 519.7 miles Ronald Budzik MD None None
Medical University of South Carolina - Charleston, South Carolina 672.0 miles Adrian Parker 843-792-3164 parkerad@musc.edu
Tennessee Interventional Associates - Chattanooga, Tennessee 782.3 miles Blaise Baxter MD None None
Vanderbilt University - Nashville, Tennessee 811.9 miles J Mocco MD None None
Baptist Health - Jacksonville, Florida 890.4 miles Ricardo Hanel MD None None
Methodist Healthcare Memphis - Memphis, Tennessee 1,002.7 miles Adam Arthur MD None None
Wisconsin University - Madison, Wisconsin 2,428.7 miles Beverly AagaardKienitz MD None None

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