Status and phase
Conditions
Treatments
About
A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well
Full description
Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterior circulation ischemic stroke between 8 and 24 hours from time last seen well. Randomization will be done under a minimization process using age (≤68 vs. >68 years), baseline NIHSS (<17 v. ≥17), ASPECTS (5-7 vs. 8-10), therapeutic window (6-12 or 12-24 hours after TLKW), occlusion site (Intracranial ICA or M1), and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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 clinical improvement.
No significant pre-stroke functional disability (mRS ≤2)
Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging)
Age ≥18 years (no upper age limit)
Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
The presence of Age-Adjusted modified Clinical ASPECTS Mismatch (mCAM) defined as ASPECTS 5-10 and one of the following criteria:
Patient treatable within 6-24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as arterial puncture.
Informed consent obtained from patient or acceptable patient surrogate
Exclusion criteria
-Clinical criteria
Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
Baseline platelet count < 30.000/µL
Baseline blood glucose of < 50mg/dL
Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
Patients in coma defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
Seizures at stroke onset which would preclude obtaining a baseline NIHSS
Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
History of life-threatening allergy (more than rash) to contrast medium
Subjects who has received IV t-PA treatment beyond 4.5 hours from the beginning of the symptoms
Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
Subject participating in a study involving an investigational drug or device that would impact this study.
Cerebral vasculitis
Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
Hypodensity on CT or restricted diffusion on MRI amounting to an ASPECTS score of <5.
Complete involvement of more than 3 cortical ASPECTS areas (e.g. M1, M2, M3, M4, M5, or M6).
Complete absence of leptomeningeal collaterals on CT angiography (e.g. Malignant CTA pattern or score 0).
CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).
Significant mass effect with midline shift.
Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
Evidence of intracranial tumor (except small meningioma).
Primary purpose
Allocation
Interventional model
Masking
376 participants in 2 patient groups
Loading...
Central trial contact
Sheila CO Martins, MD, PhD; Natacha Fleck
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal