Status:
TERMINATED
POSITIVE Stroke Clinical Trial
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Vanderbilt University
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Primary Endpoint: The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, with appropriate image selection, treated with mechanical thrombectomy wit...
Detailed Description
Intravenous (IV) tissue plasminogen activator (tPA) administration has been shown to be safe and effective for treatment of AIS within 3 hours of symptom onset, and newer evidence has shown potential ...
Eligibility Criteria
Inclusion
- Age 18 and older (i.e., candidates must have had their 18th birthday)
- NIHSS ≥8 at the time of neuroimaging
- Presenting or persistent symptoms within 6-12 hours of when groin puncture can be obtained
- Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA M1 bifurcation)
- The operator feels that the stroke can be appropriately treated with traditional endovascular techniques (endovascular mechanical thrombectomy without adjunctive devices such as stents)
- Pts are within 6-12 hours of symptom onset, that have received IV-tPA without improvement in symptoms are eligible for this study. Patients presenting earlier than 6 hours should be treated according to local standard of care.
- Pre-event Modified Rankin Scale score 0-1
- Consenting requirements met according to local IRB
Exclusion
- Patient is less than 6-hours from symptom onset
- Rapidly improving neurologic examination
- Absence of large vessel occlusion on non-invasive imaging
- Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
- Absence of an associated large penumbra as defined by physiologic imaging according to standard of practice at the participating institution
- Any intracranial hemorrhage in the last 90 days
- Known irreversible bleeding disorder
- 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
- Platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction
- Inability to tolerate, clinically documented evidence in medical history of adverse reaction to, or contraindication to medications used in treatment of the stroke
- Contraindication to CT and MRI (i.e., iodine contrast allergy or other condition that prohibits imaging from either CT or MRI)
- Known allergy to contrast used in angiography that cannot be medically controlled
- Relative contraindication to angiography (e.g., serum creatinine \> 2.5 mg/dL)
- Women who are currently pregnant or breast-feeding (Women of child-bearing potential must have a negative pregnancy test prior to the study procedure (either serum or urine)
- Evidence of active infection (indicated by fever at or over 99.9 °F and/or open draining wound) at the time of randomization
- Current use of cocaine or other vasoactive substance
- Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
- Patients who lack the necessary mental capacity to participate or are unwilling or unable to comply with the protocol's follow up appointment schedule (based on the investigator's judgment)
- Head CT or MRI Scan Exclusion Criteria
- Presence of blood on imaging (subarachnoid hemorrhage (SAH), intracerebral hemorrhage (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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01852201
Start Date
September 1 2013
End Date
May 31 2017
Last Update
November 13 2019
Active Locations (20)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Swedish/Colorado Neurological Institute
Englewood, Colorado, United States, 80113
4
Baptist Health
Jacksonville, Florida, United States, 32207