Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01852201
Status:
TERMINATED
Last Update Posted:
2019-11-13
First Post:
2013-04-23
Brief Title:
POSITIVE Stroke Clinical Trial
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
POSITIVE PerfusiOn Imaging Selection of Ischemic STroke PatIents for EndoVascular ThErapy
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 72
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 SAEs
Arterial revascularization measured by TICI 2b or 3 following device use
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 72
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 SAEs
Arterial revascularization measured by TICI 2b or 3 following device use
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 benefit out to 45 hours Mechanical thrombectomy for AIS patients has been shown in clinical trials to be safe up to 8 hours after symptom onset The rapid progression of thrombectomy devices over the last several years has resulted in faster recanalization times while maintaining a high degree of safety This has resulted in improved patient outcomes similar to prior randomized trial data showing improved outcomes over medical therapy or earlier devices Data from the MERCI trial suggests that patients 85 as well as those with a baseline NIHSS score 30 are unlikely to benefit from thrombectomy Patients with rapidly improving neurologic deficits likely will have an excellent recovery with conventional care precluding the ability to detect a beneficial treatment effect of thrombectomy
Pilot data incorporating physiologic imaging has shown that appropriate patients can be selected for thrombectomy This selection methodology has shown the ability to maintain the same level of safety and efficacy as those patients treated in the highly selective environment of a clinical trial despite presenting far beyond accepted time based standards Vertebrobasilar occlusion patients are excluded to maintain a homogenous study population particularly since no data currently is available addressing the comparability of imaging penumbral patterns in the anterior vs posterior circulation This has also been shown to be reproducible at multiple centers and with different imaging modalities However all prospective interventional stroke studies performed to date have been restricted by the 8-hour time window
Pilot data incorporating physiologic imaging has shown that appropriate patients can be selected for thrombectomy This selection methodology has shown the ability to maintain the same level of safety and efficacy as those patients treated in the highly selective environment of a clinical trial despite presenting far beyond accepted time based standards Vertebrobasilar occlusion patients are excluded to maintain a homogenous study population particularly since no data currently is available addressing the comparability of imaging penumbral patterns in the anterior vs posterior circulation This has also been shown to be reproducible at multiple centers and with different imaging modalities However all prospective interventional stroke studies performed to date have been restricted by the 8-hour time window
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None