![]() ![]() Subject participating in a study involving an investigational drug or device that would impact this study. Woman of childbearing potential who is known to be pregnant or lactating or who has a positive pregnancy test on admission. ![]() Renal insufficiency with creatinine ≥ 3 mg/dl Subjects who has received iv t-PA treatment beyond 4,5 hours from the beginning of the symptoms History of life threatening allergy (more than rash) to contrast medium Serious, advanced, or terminal illness with anticipated life expectancy of less than one year. Seizures at stroke onset which would preclude obtaining a baseline NIHSS Patients in coma (NIHSS item of consciousness >1) (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation). ![]() Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0 Informed consent obtained from patient or acceptable patient surrogate Treatment start is defined as groin puncture. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Patient treatable within eight hours of symptom onset. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions), MCA-M1 segment or tandem proximal ICA/MCA-M1 suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis Baseline NIHSS score obtained prior to randomization must be equal or higher than 6 points No significant pre-stroke functional disability (mRS ≤ 1) Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without recanalization after a minimum of 30 min from start of iv tPA infusion Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. Subject population: Subjects presenting with acute ischemic stroke within 8 hours from symptom onset and whose strokes are attributable to an occlusion of the internal carotid or proximal MCA (M1) arteries. Of note, sample size adjustment based on different than expected outcomes rates is permitted, but it is not permitted to adjust the sample size based on change in the pre-specified treatment effect which is set at 10%. The latter may be necessary as given the paucity of data regarding natural history of the non-treated patients assumptions regarding rates of favorable outcomes in this group of patients may be incorrect. #PRE ACTIVE PRETTY GOOD SOLITAIRE TRIAL#The DSMB will advise the executive committee (EC) on recommendations to stop the trial early either for reasons of safety, efficacy, futility or to adjust the sample size. Interim analysis will be performed as preplanned and interpreted by the Data Safety Monitoring Board (DSMB) after the first 174, 346 and 518 patients representing 25%, 50% and 75% of the planned sample size have completed their 90-day follow-up. For the primary endpoint, subjects will be followed for 90 days post-randomization. Randomization will be done under a minimization process using age, baseline NIHSS, therapeutic window and vessel occlusion site. The randomization employs a 1:1 ratio of mechanical embolectomy with the CE MARK approved stentriever Solitaire FR® versus medical management alone. Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. Why Should I Register and Submit Results?. ![]()
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