Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)
NCT ID: NCT03753061
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
204 participants
INTERVENTIONAL
2018-11-22
2020-03-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients
NCT05667103
RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study
NCT01983644
Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion
NCT06427187
Endovascular Treatment and RIPC in Acute Ischemic Stroke
NCT04581759
A Multicenter, Randomized Controlled Clinical Investigation to Evaluate the Safety and Effectiveness of the Super-Bore 8/7F Aspiration Catheters in the Treatment of Acute Intracranial Large Vessel Occlusion
NCT06559475
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this trial, relevant examinations of safety and efficacy assessments were performed immediately after the procedure, at 24 hours, 7 days, 30 days, and 90 days. Primary efficacy endpoint will be the immediate recanalization rate (mTICI 2b-3) of target vessel after the procedure. Secondary efficacy endpoints will include: (1) Proportion of functional independence (mRS 0-2) at 90 days; (2) ordinal shift analysis of mRS at 90 days; (3) immediate recanalization rate (mTICI 2b-3) of the first pass of thrombectomy device; (4) immediate recanalization rate (mTICI 2b-3) of the last pass of thrombectomy device; (5)procedure time (randomization to recanalization); (6) Change in NIHSS score at 24hours; (7) Change in NIHSS score at 7 days or discharge (whichever comes first); (8) mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours; (9) The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI. Safety endpoints will include: (1) All-cause mortality at 90 days; (2) stroke-related mortality at 90 days; (3) stroke recurrence rate within 90 days; (4) any type of intracranial hemorrhagic transformation within 22-36 hours, including parenchymal, subarachnoid or ventricular hemorrhage; (5) symptomatic intracranial hemorrhage (sICH) within 22-36 hours, as confirmed by any intracranial hemorrhage on CT or MRI associated with ≥ 4 points of worsening on NIHSS or even contributing to death; (5) procedural complications or serious adverse events procedural complications or serious adverse events (SAEs) within 90 days.
The trial is anticipated to last from November 2018 to May 2019, all the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Aspiration Catheter
Mechanical thrombectomy with Aspiration Catheter.
Aspiration Catheter
Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.
Stent Retriever (Solitaire FR)
Mechanical thrombectomy with Solitaire FR.
Solitaire FR
Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aspiration Catheter
Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.
Solitaire FR
Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Symptoms and signs in accordance with anterior circulation ischemia and large vessel occlusion (ICA, MCA-M1 or M2) confirmed by CTA/MRA/DSA.
3. Pre-stroke Modified Rankin Scale（mRS）0-1.
4. NIHSS score ≥ 6 points at time of randomization.
5. 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.
6. 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.
7. Written informed consent obtained from patient or patient's legally authorized representative.
Exclusion Criteria
2. Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging.
3. 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.
4. Proven occlusion of the common carotid artery.
5. Known or suspected chronic occlusion of target vessel.
6. Known life threatening allergy (more than rash) to iodinated contrast agent.
7. Arterial tortuosity and other problems that would prevent the device from reaching the target vessel.
8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.
9. Baseline platelet count \< 50000/µL.
10. Severe heart, liver or kidney failure and other serious or terminal illness.
11. Major surgery within the past 2 weeks
12. Haemorrhage of the gastrointestinal or urinary tract within the past 3 weeks.
13. Baseline blood glucose \< 2.7 or \> 22.2 mmol/L.
14. Baseline blood pressure \> 185/110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits
15. Pregnant or lactating or positive pregnancy test on admission.
16. Dementia or psychiatric disease that would confound the neurological or functional evaluations.
17. Life expectancy less than 1 year.
18. Current participation in another drug or device research.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhongrong Miao
Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Luhe Hospital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Tangshan People's Hospital
Tangshan, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
Henan Province People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhengzhou Central Hospital
Zhengzhou, Henan, China
Taihe Hospital
Shiyan, Hubei, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Baotou Central Hospital
Baotou, Neimenggu, China
Tangdu Hospital
Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Liaocheng People's Hospital
Liaocheng, Shandong, China
Qingdao Central Hospital
Qingdao, Shandong, China
Weihai Central Hospital
Weihai, Shandong, China
Yantaishan Hospital
Yantai, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Quanshan Ai
Role: primary
Xiaokun Geng
Role: primary
Zhongrong Miao, MD
Role: primary
Zhou Xing
Role: primary
Zhiqiang Li
Role: primary
Yan Wang
Role: primary
Liping Wei
Role: primary
Tianxiao Li
Role: primary
Sheng Guan
Role: primary
Haibo Wang
Role: primary
Zhibing Ai
Role: primary
Xinchun Ye
Role: primary
Changchun Jiang
Role: primary
Zhenwei Zhao
Role: primary
Jianfeng Han
Role: primary
Wei Wu
Role: primary
Liyong Zhang
Role: primary
Haicheng Yuan
Role: primary
Hongjun Hou
Role: primary
Dianjing Sun
Role: primary
Jin Zhang
Role: primary
Binge Chang
Role: primary
Li Yang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HEMO-CS1802
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.