Last updated: February 10, 2023
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting
Phase
3
Condition
Stroke
Cerebral Ischemia
Cardiac Ischemia
Treatment
N/AClinical Study ID
NCT05634382
HOPE-BRIDGING
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patient/Legally Authorized Representative has signed the Informed Consent form
- Age ≥ 18
- Clinical signs consistent with an acute ischemic stroke
- Neurological deficit with a NIHSS of ≥ 6 (deficits judged to be clearly disabling atpresentation)
- Patient is eligible for intravenous thrombolysis
- Patient is eligible for endovascular treatment
- Randomization no later than 8 hours 45 minutes after stroke symptom onset andinitiation of IV t-PA must be started within 9 hours of stroke symptoms onset (forstroke with unknown time of onset, the midpoint of the time last known to be well andsymptom recognition time)
- ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with orwithout tandem MCA lesions) by MRA or CTA (including the reconstructed CTA derivedfrom CTP). And target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is >/= 1.8 and mismatch volume is >/= 15 ml)
- Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 based onbaseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% ormore of its volume to be considered MR-ASPECTS positive)
Exclusion
Exclusion Criteria:
- Acute intracranial hemorrhage
- Any contraindication for IV t-PA
- Pre-treatment with IV t-PA
- Pregnancy or lactating women. A negative pregnancy test before randomization isrequired for all women with child-bearing potential.
- Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals,or their alloys
- Known current participation in a clinical trial (investigational drug or medicaldevice)
- Renal insufficiency as defined by a serum creatinine > 2.0 mg/dl (or 176.8 µmol/l) orglomerular filtration rate (GFR) < 30 mL/min or requirement for hemodialysis orperitoneal dialysis
- Severe comorbid condition with life expectancy less than 90 days at baseline
- Known advanced dementia or significant pre-stroke disability (mRS score of ≥2)
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients livingabroad)
- Comorbid disease or condition that would confound the neurological and functionalevaluations or compromise survival or ability to complete follow-up assessments
- Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).
- Known history of arterial tortuosity, pre-existing stent, other arterial diseaseand/or known disease at the femoral access site that would prevent the device fromreaching the target vessel and/or preclude safe recovery after MT
- Radiological confirmed evidence of mass effect or intracranial tumor (except smallmeningioma)
- Radiological confirmed evidence of cerebral vasculitis
- CTA or MRA evidence of carotid artery dissection
- Evidence of additional distal intracranial vessel occlusion in another territory (i.e.A2 segment of anterior cerebral artery or M3, M4 segment of MCA) on initial NCCT/MRIor CTA/MRA
Study Design
Total Participants: 222
Study Start date:
December 03, 2022
Estimated Completion Date:
February 28, 2025
Study Description
Connect with a study center
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
ChinaActive - Recruiting
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