Status:
UNKNOWN
Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)
Lead Sponsor:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Large Vessel Occlusion
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, multi-center, open-label, end-point blinded, randomized, parallel positive control, non-inferiority clinical trial, with a purpose to evaluate the safety and efficacy of H...
Detailed Description
This study is a prospective, multi-center, open-label, end-point blinded, parallel positive controlled, non-inferiority clinical trial. Patients with acute ischemic stroke (AIS) who meet inclusion cri...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Symptoms and signs in accordance with anterior circulation ischemia and large vessel occlusion (ICA, MCA-M1 or M2) confirmed by CTA/MRA/DSA.
- Pre-stroke Modified Rankin Scale（mRS）0-1.
- NIHSS score ≥ 6 points at time of randomization.
- The patients should receive endovascular treatment within 8 hours of estimated time of large vessel occlusion (LVO) onset, and have an ASPECTS ≥ 6 points on non-enhanced CT.
- If intravenous thrombolysis with tPA (IVT) is considered as part of standard medical management, IVT should be started within 4.5 hours of estimated time of LVO. Furthermore, in AIS patients with an unknown time of onset, IVT guided by a mismatch between DWI and FLAIR in the region of ischemia is also recommended.
- Written informed consent obtained from patient or patient's legally authorized representative.
Exclusion
- Acute posterior circulation cerebral infarction comfirmed by CT or MRI.
- Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging.
- Large (more than one-third of the MCA) regions of clear hypodensity on the baseline CT scan or ASPECTS \< 7 points or significant mass effect with midline shift.
- Proven occlusion of the common carotid artery.
- Known or suspected chronic occlusion of target vessel.
- Known life threatening allergy (more than rash) to iodinated contrast agent.
- Arterial tortuosity and other problems that would prevent the device from reaching the target vessel.
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.
- Baseline platelet count \< 50000/µL.
- Severe heart, liver or kidney failure and other serious or terminal illness.
- Major surgery within the past 2 weeks
- Haemorrhage of the gastrointestinal or urinary tract within the past 3 weeks.
- Baseline blood glucose \< 2.7 or \> 22.2 mmol/L.
- Baseline blood pressure \> 185/110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits
- Pregnant or lactating or positive pregnancy test on admission.
- Dementia or psychiatric disease that would confound the neurological or functional evaluations.
- Life expectancy less than 1 year.
- Current participation in another drug or device research.
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2020
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03753061
Start Date
November 22 2018
End Date
March 20 2020
Last Update
September 19 2019
Active Locations (23)
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1
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100000
2
Beijing Luhe Hospital Medical University
Beijing, Beijing Municipality, China, 100000
3
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
4
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000