Status:
COMPLETED
Direct Intra-arterial Thrombectomy in Order to Revascularize AIS Patients With Large Vessel Occlusion Efficiently in Chinese Tertiary Hospitals
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
National Health and Family Planning Commission, P.R.China
Wu Jieping Medical Foundation
Conditions:
Ischemic Stroke
Large Vessel Occlusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Intravenous thrombolysis (IVT) combined with mechanical thrombectomy (MT) has been proven safe and effective in patients with acute ischemic stroke (AIS) of anterior circulation large vess...
Detailed Description
Protocol title: Direct Intra-arterial thrombectomy in order to Revascularize AIS patients with large vessel occlusion Efficiently in Chinese Tertiary hospitals: a Multicenter randomized clinical Trial...
Eligibility Criteria
Inclusion
- a clinical diagnosis of acute ischemic stroke,
- caused by a large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle M1/proximal M2) cerebral artery confirmed by CTA,
- CT or MRI ruling out intracranial hemorrhage,
- eligible for IVT and IAT (within 4.5 hours after symptom onset),
- a score of at least 2 on the NIH Stroke Scale,
- age of 18 years or older,
- written informed consent.
Exclusion
- \- Pre-stroke disability which interferes with the assessment of functional outcome at 90 days, i.e. mRS \>2
- Any contra-indication for IVT, according to guidelines of the American Heart Association, i.e.:
- arterial blood pressure exceeding 185/110 mmHg
- blood glucose less than 2.7 or over 22.2 mmol/L
- cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
- serious head trauma in the previous 3 months
- major surgery or serious trauma in the previous 2 weeks
- gastrointestinal or urinary tract hemorrhage in the previous 3 weeks
- previous intracerebral hemorrhage
- use of anticoagulant with INR exceeding 1.7
- known thrombocyte count less than 100 x 109/L
- treatment with direct thrombin or factor X inhibitors
- treatment with heparin (APTT exceeds the upper limit of normal value) in the previous 48 hours.
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2019
Estimated Enrollment :
656 Patients enrolled
Trial Details
Trial ID
NCT03469206
Start Date
February 21 2018
End Date
October 26 2019
Last Update
October 29 2019
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433