POSITIVE Stroke Clinical Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01852201
• Date of registration: 23/04/2013
• Prospective Registration: Yes
• Primary sponsor: Medical University of South Carolina
• Public title: POSITIVE Stroke Clinical Trial
• Scientific title: POSITIVE: PerfusiOn Imaging Selection of Ischemic STroke PatIents for EndoVascular ThErapy
• Date of first enrolment: September 2013
• Target sample size: 33
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01852201
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Jonathan Lena, MD
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18 and older (i.e., candidates must have had their 18th birthday)

2. NIHSS =8 at the time of neuroimaging

3. Presenting or persistent symptoms within 6-12 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 mechanical thrombectomy without adjunctive
devices such as stents)

6. 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.

7. Pre-event Modified Rankin Scale score 0-1

8. Consenting requirements met according to local IRB

Exclusion Criteria:

1. Patient is less than 6-hours from symptom onset

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. Any intracranial hemorrhage in the last 90 days

7. Known irreversible bleeding disorder

8. 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

9. Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction

10. Inability to tolerate, clinically documented evidence in medical history of adverse
reaction to, or contraindication to medications used in treatment of the stroke

11. Contraindication to CT and MRI (i.e., iodine contrast allergy or other condition that
prohibits imaging from either CT or MRI)

12. Known allergy to contrast used in angiography that cannot be medically controlled

13. Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL)

14. 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)

15. Evidence of active infection (indicated by fever at or over 99.9 °F and/or open
draining wound) at the time of randomization

16. Current use of cocaine or other vasoactive substance

17. Any comorbid disease or condition expected to compromise survival or ability to
complete follow-up assessments through 90 days

18. 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ischemic Stroke

Intervention(s)

Device: Endovascular Mechanical Thrombectomy

Primary Outcome(s)

Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) [Time Frame: 90 days]

Secondary Outcome(s)

Percentage of Participants With ICH (Intracranial Hemorrhage) With Neurological Deterioration (NIHSS Worsening >4). [Time Frame: 90 days]

Percentage of Participants With SAE's Related to a Thrombectomy Procedure [Time Frame: 90 days]

Arterial Revascularization Measured by TICI 2b or 3 Following Device Use [Time Frame: 90 days]

Percentage of Participants Mortality at 30 Days [Time Frame: 30 days]

Percentage of Patients With Serious Adverse Events (SAEs) Related to Thrombectomy Device. [Time Frame: 90 days]

Percentage of Participants in the 6-12 hr Cohort With Global Disability as Assessed by the Modified Rankin Score (mRS) [Time Frame: 90 day]

Percentage of Participants Mortality at 90 Days [Time Frame: 90 days]

Percentage of Participants in the 6-12hr Cohort With Good Functional Recovery as Assessed by the Modified Rankin Scale (mRS) [Time Frame: 90 days]

Secondary ID(s)

PRO23329

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vanderbilt University

Results

• Results available: Yes
• Date Posted: 13/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01852201