Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial in the Extended Time Window
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stroke, Ischemic
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 376
- Locations
- 14
- Primary Endpoint
- Modified Rankin Scale scores
- Last Updated
- 5 years ago
Overview
Brief Summary
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
Detailed 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.
Investigators
SHEILA CRISTINA OURIQUES MARTINS
Principal Investigator
Hospital de Clinicas de Porto Alegre
Eligibility Criteria
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:
- •NIHSS ≥ 8 and \>50% involvement in 0-1 Cortical (e.g. M1-6) ASPECTS areas (any age);
- •NIHSS ≥ 8 and \>50% involvement in 0-2 Cortical (e.g. M1-6) ASPECTS areas (and age \< 80 years old);
- •NIHSS ≥ 15 and \>50% involvement in 0-3 Cortical (e.g. M1-6) ASPECTS areas (and age \< 80 years old).
- •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.
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
Outcomes
Primary Outcomes
Modified Rankin Scale scores
Time Frame: 90 days
Distribution of the modified Rankin Scale scores at 90 days (shift analysis). The score range from zero to 6 with higher values indicating a worst functional outcome at 90 days
Secondary Outcomes
- Procedural related complications(immediately after procedure)
- Proportion of patients with Intracranial Hemorrhage at 24 hours(24 hours)
- Proportion of Patients with Functional independence in 90 days(90 days)
- Disability on the utility-weighted modified Rankin scale (UW-mRS)(90 days)
- Quality of life measured by EuroQol Group 5-Dimension Self-Report Questionnaire (EuroQol / EQ5D)(90 days and 1 year)
- Mortality at 90 days(90 days)