POSITIVE Stroke Clinical Trial
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
Estimated Completion Date
- Device: Endovascular Mechanical Thrombectomy
- Neurology: Stroke/Vascular
- Endovascular Mechanical Thrombectomy
- intra-arterial reperfusion
Medical University of South Carolina -- PRO23329
Medical University of South Carolina
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
4. Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA M1
5. The operator feels that the stroke can be appropriately treated with traditional
endovascular techniques (endovascular thrombectomy without adjunctive devices such as
6. Pre-event Modified Rankin Scale score 0-1
7. Consenting requirements met according to local IRB
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
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
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
20. Currently participating in another interventional (drug, device, etc) research
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.
18 Years to 80 Years
Accepts Healthy Volunteers
Study Locations and Contact Information (13)
|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 Parkerfirstname.lastname@example.org|
|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|