Ischemic Stroke Clinical Trial
Official title:
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
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 4.5 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05196659 -
Collaborative Quality Improvement (C-QIP) Study
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Recruiting |
NCT05518305 -
Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
|
||
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT03728738 -
Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke
|
Phase 3 | |
Terminated |
NCT03396419 -
IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
|
||
Recruiting |
NCT05065216 -
Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)
|
Phase 2/Phase 3 | |
Recruiting |
NCT04897334 -
Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke
|
N/A | |
Not yet recruiting |
NCT06462599 -
Osteopontin Gene Polymorphism in Stroke Patients in Egypt
|
||
Not yet recruiting |
NCT06026696 -
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
|
||
Not yet recruiting |
NCT06032819 -
Differentiating Between Brain Hemorrhage and Contrast
|
||
Recruiting |
NCT02910180 -
Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
|
||
Completed |
NCT03554642 -
Walkbot Robotic Training for Improvement in Gait
|
Phase 3 | |
Completed |
NCT02922452 -
A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
|
Phase 1 | |
Withdrawn |
NCT01866189 -
Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke
|
N/A | |
Recruiting |
NCT03041753 -
Reperfusion Injury After Stroke Study
|
N/A | |
Completed |
NCT02549846 -
AdminiStration of Statin On Acute Ischemic stRoke patienT Trial
|
Phase 4 | |
Completed |
NCT02610803 -
Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke
|
N/A | |
Completed |
NCT01678534 -
Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial
|
Phase 2 |