Status:
SUSPENDED
A Randomized Trial Of Endovascular Treatment For Acute Posterior Large Vessel Occlusion
Lead Sponsor:
Xinqiao Hospital of Chongqing
Conditions:
Vertebrobasilar Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this trial is to investigate whether endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the posterior circulation.
Detailed Description
At least seven randomized controlled trials have consistently shown that endovascular treatment can improve the functional outcome of stroke patients with acute anterior large vessel occlusion. Howeve...
Eligibility Criteria
Inclusion
- Age: i. 18 \~ 80 years old, pc-ASPECTS score ≥ 6; ii. \> 80 years old, pc-ASPECTS score ≥ 8 and mRS = 0 before the onset
- NIHSS score ≥ 10 before randomization;
- VA-V4 or basilar artery occlusion proved by CTA/MRA/DSA;
- Time from stroke onset to randomization within 23.5 hours;
- Written informed consent is obtained from patients and/or their legal representatives.
Exclusion
- CT or MR evidence of intracranial hemorrhage;
- Pre-morbidity with a modified Rankin scale score ≥ 3;
- The patient is in deep coma;
- Currently in pregnant or lactating or serum beta HCG test is positive on admission;
- Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
- Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
- Significant mass effect in the cerebellar hemisphere or hydrocephalus on imaging;
- Imaging manifestations of diffuse bilateral brainstem ischemia;
- Multivessel occlusive disease (combined with anterior and posterior circulation occlusion or subtotal occlusion);
- Cerebral vasculitis, intracranial arteriovenous malformation, aneurysm, or brain tumor with mass effect;
- Participating in other clinical trials;
- Any terminal illness with life expectancy less than 6 months;
- Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
- Past neurological or psychiatric diseases that hinder the assessment of neurological function;
- Unlikely to be available for 90-day follow-up.
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 16 2024
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT04743076
Start Date
March 16 2021
End Date
May 16 2024
Last Update
September 14 2021
Active Locations (16)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
2
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China, 241000
3
Banan District People's Hospital
Banan, Chongqing Municipality, China, 400040
4
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 400037