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Trial record 19 of 35 for:    mechanical thrombectomy | Recruiting Studies | stroke

Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)

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ClinicalTrials.gov Identifier: NCT03753061
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongrong Miao, Beijing Tiantan Hospital

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.

Condition or disease Intervention/treatment Phase
Large Vessel Occlusion Acute Ischemic Stroke Cerebrovascular Disorders Device: Aspiration Catheter Device: Solitaire FR Not Applicable

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 criteria would be enrolled in this study. Led by Beijing Tiantan Hospital affiliated to Capital Medical University, this study is planned to be carried out in 15-20 clinical trial institutions in China. There will be 102 patients enrolled in each group. Patients in the experimental group will be treated with the intracranial thrombus aspiration catheter, product of Hemo Jirui. Patients in the control group will be treated with stent retriever (Solitaire FR).

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : March 20, 2020
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arm Intervention/treatment
Experimental: Aspiration Catheter
Mechanical thrombectomy with Aspiration Catheter.
Device: Aspiration Catheter
Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.

Active Comparator: Stent Retriever (Solitaire FR)
Mechanical thrombectomy with Solitaire FR.
Device: Solitaire FR
Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.




Primary Outcome Measures :
  1. Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. Proportion of functional independence (mRS 0-2) at 90 days [ Time Frame: 90 days ]
  2. Ordinal shift analysis of mRS at 90 days [ Time Frame: 90 days ]
  3. Instant recanalization rate (mTICI 2b-3) after the first thrombectomy [ Time Frame: immediate ]
  4. Instant recanalization rate (mTICI 2b-3) after the last thrombectomy [ Time Frame: immediate ]
  5. Procedure time (randomization to recanalization) [ Time Frame: procedure ]
  6. Change in NIHSS score at 24±2 hours [ Time Frame: 24 hours ]
  7. Change in NIHSS score at 7±1 days or discharge (whichever comes first) [ Time Frame: 7 days ]
  8. mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours [ Time Frame: 22-36 hours ]
  9. The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI [ Time Frame: 22-36 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  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:

  1. Acute posterior circulation cerebral infarction comfirmed by CT or MRI.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753061


Contacts
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Contact: Zhongrong Miao, MD 86-010-67098857 13601243293@163.com
Contact: Yan Lin, Master 86-13911573513 yan.lin@hemochina.com

Locations
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China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100000
Contact: Quanshan Ai         
Principal Investigator: Quanshan Ai         
Beijing Luhe Hospital Medical University Recruiting
Beijing, Beijing, China, 100000
Contact: Xiaokun Geng         
Principal Investigator: Xiaokun Geng         
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100070
Contact: Zhongrong Miao, MD         
Principal Investigator: Zhongrong Miao, MD         
China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Zhou Xing         
Principal Investigator: Zhou Xing         
Principal Investigator: Xinguang Yang         
China, Hebei
Affiliated Hospital of Hebei University Recruiting
Baoding, Hebei, China, 071000
Contact: Zhiqiang Li         
Principal Investigator: Zhiqiang Li         
Tangshan People's Hospital Recruiting
Tangshan, Hebei, China, 063000
Contact: Yan Wang         
Principal Investigator: Yan Wang         
China, Henan
Luoyang Central Hospital Recruiting
Luoyang, Henan, China, 471000
Contact: Liping Wei         
Principal Investigator: Liping Wei         
Henan Province People's Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Tianxiao Li         
Principal Investigator: Tianxiao Li         
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450000
Contact: Sheng Guan         
Principal Investigator: Sheng Guan         
Zhengzhou Central Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Haibo Wang         
Principal Investigator: Haibo Wang         
China, Hubei
Taihe Hospital Recruiting
Shiyan, Hubei, China, 442000
Contact: Zhibing Ai         
Principal Investigator: Zhibing Ai         
China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China, 221000
Contact: Xinchun Ye         
Principal Investigator: Xinchun Ye         
China, Neimenggu
Baotou Central Hospital Recruiting
Baotou, Neimenggu, China, 014000
Contact: Changchun Jiang         
Principal Investigator: Changchun Jiang         
China, Shaanxi
Tangdu Hospital Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Zhenwei Zhao         
Principal Investigator: Zhenwei Zhao         
The First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Jianfeng Han         
Principal Investigator: Jianfeng Han         
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250000
Contact: Wei Wu         
Principal Investigator: Wei Wu         
Liaocheng People's Hospital Recruiting
Liaocheng, Shandong, China, 252000
Contact: Liyong Zhang         
Principal Investigator: Liyong Zhang         
Qingdao Central Hospital Recruiting
Qingdao, Shandong, China, 266000
Contact: Haicheng Yuan         
Principal Investigator: Haicheng Yuan         
Weihai Central Hospital Recruiting
Weihai, Shandong, China, 264400
Contact: Hongjun Hou         
Principal Investigator: Hongjun Hou         
Yantaishan Hospital Recruiting
Yantai, Shandong, China, 264000
Contact: Dianjing Sun         
Principal Investigator: Dianjing Sun         
China, Shanxi
First Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China, 030000
Contact: Jin Zhang         
Principal Investigator: Jin Zhang         
China, Tianjin
Tianjin First Central Hospital Recruiting
Tianjin, Tianjin, China, 300000
Contact: Binge Chang         
Principal Investigator: Binge Chang         
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300000
Contact: Li Yang         
Principal Investigator: Li Yang         
Sponsors and Collaborators
Ministry of Science and Technology of the People´s Republic of China

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Responsible Party: Zhongrong Miao, Chief of the Department of Interventional Neurology in Beijing Tiantan Hopital, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03753061     History of Changes
Other Study ID Numbers: HEMO-CS1802
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhongrong Miao, Beijing Tiantan Hospital:
Large vessel occlusion
Acute ischemic stroke
Endovascular treatment
Mechanical thrombectomy
Aspiration Catheter
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Cerebrovascular Disorders
Intracranial Thrombosis
Thrombosis
Ischemia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Thromboembolism