Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)
The Safety and Efficacy of Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy- A Prospective, Multicenter, Open Label, Blinded, Randomized Controlled, Non-inferiority Study
1 other identifier
interventional
204
1 country
23
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 Hemo Jirui intracranial thrombus aspiration catheter system for endovascular treatment of acute ischemic stroke by comparison with stent retriever (Solitaire FR). The trial is anticipated to last from November 2018 to May 2019, with 204 subjects recruited from 15-20 clinical trial centers in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2018
CompletedStudy Start
First participant enrolled
November 22, 2018
CompletedFirst Posted
Study publicly available on registry
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2020
CompletedSeptember 19, 2019
September 1, 2019
1.3 years
November 21, 2018
September 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
immediate
Secondary Outcomes (9)
Proportion of functional independence (mRS 0-2) at 90 days
90 days
Ordinal shift analysis of mRS at 90 days
90 days
Instant recanalization rate (mTICI 2b-3) after the first thrombectomy
immediate
Instant recanalization rate (mTICI 2b-3) after the last thrombectomy
immediate
Procedure time (randomization to recanalization)
procedure
- +4 more secondary outcomes
Study Arms (2)
Aspiration Catheter
EXPERIMENTALMechanical thrombectomy with Aspiration Catheter.
Stent Retriever (Solitaire FR)
ACTIVE COMPARATORMechanical thrombectomy with Solitaire FR.
Interventions
Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.
Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000, China
Beijing Luhe Hospital Medical University
Beijing, Beijing Municipality, 100000, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000, China
Tangshan People's Hospital
Tangshan, Hebei, 063000, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
Henan Province People's Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000, China
Taihe Hospital
Shiyan, Hubei, 442000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Baotou Central Hospital
Baotou, Neimenggu, 014000, China
Tangdu Hospital
Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Qingdao Central Hospital
Qingdao, Shandong, 266000, China
Weihai Central Hospital
Weihai, Shandong, 264400, China
Yantaishan Hospital
Yantai, Shandong, 264000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital
Study Record Dates
First Submitted
November 21, 2018
First Posted
November 26, 2018
Study Start
November 22, 2018
Primary Completion
March 20, 2020
Study Completion
March 20, 2020
Last Updated
September 19, 2019
Record last verified: 2019-09