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POSITIVE: PerfusiOn Imaging Selection of Ischemic STroke PatIents for EndoVascular ThErapy
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 within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT with respect to endpoint defined as: • 90-day global disability assessed via the modified Rankin score (mRS), analyzed using raw mRS scores. Statistical details can be found in section 7.2. Secondary Endpoints: * 90-day global disability in the 6-12 hr cohort assessed via the overall distribution of mRS * Proportion of patients with good functional recovery for the 6-12 hr cohort as defined by mRS 0-2 at 90 days * Mortality at 30 and 90 days * Intracranial hemorrhage with neurological deterioration (NIHSS worsening \>4) within 24 hours of randomization * Procedure related serious adverse events (SAE's) * Arterial revascularization measured by TICI 2b or 3 following device use
Details
| Lead sponsor | Medical University of South Carolina |
|---|---|
| Phase | NA |
| Status | TERMINATED |
| Enrolment | 33 |
| Start date | 2013-09 |
| Completion | 2017-05-31 |
Conditions
- Ischemic Stroke
Interventions
- Endovascular Mechanical Thrombectomy
Primary outcomes
- Rate of Good Functional Outcomes Measured by Modified Rankin Score (mRS) — 90 days
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2. The primary objective is to show that AIS patients, ineligible for or refractory to treatment with IV-tPA, (patients seen within 6 hours of symptom onset will be immediately considered for endovascular therapy according to the site's standard of care. Likewise, patients presenting beyond 12 hours will be treated according to the site's standard of care), with appropriate image selection, treated with mechanical thrombectomy within 6-12 hours of symptom onset have less stroke related disability and improved good functional outcomes as compared to those treated with best MT.
Countries
United States