Status:
COMPLETED
EndoVascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Ministry of Health, Brazil
Medtronic
Conditions:
Stroke
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Throm...
Detailed Description
Patients with acute ischemic stroke related to anterior circulation large vessel occlusion will be randomized up to 8 hours from symptoms onset in both arms (mechanical thrombectomy versus medical man...
Eligibility Criteria
Inclusion
- 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 ≤ 1)
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points
- Age ≥18 years
- 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.
- Patient treatable within eight 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 groin puncture.
- Informed consent obtained from patient or acceptable patient surrogate
Exclusion
- 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 or \> 400mg/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 (NIHSS item of consciousness \>1) (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 lactating 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 ≤1. 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 amounting to an ASPECTS score of \<6 on NCCT, or \<5 on DWI MRI. The use of CTP or MRI perfusion is optional.
- Collaterals with malignant profile on CTA (without colateral circulation on CTA)
- 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).
Key Trial Info
Start Date :
February 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT02216643
Start Date
February 8 2017
End Date
June 30 2019
Last Update
February 19 2020
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Geral de Fortaleza/SUS
Fortaleza, Ceará, Brazil
2
Hospital Estadual Central
Vitória, Espírito Santo, Brazil
3
Hospital Geral Roberto Santos
Salvador, Estado de Bahia, Brazil
4
Hospital de Base do Distrito Federal
Brasília, Federal District, Brazil