Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)
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| ClinicalTrials.gov Identifier: NCT03753061 |
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Recruitment Status : Unknown
Verified September 2019 by Zhongrong Miao, Beijing Tiantan Hospital.
Recruitment status was: Recruiting
First Posted : November 26, 2018
Last Update Posted : September 19, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Large Vessel Occlusion Acute Ischemic Stroke Cerebrovascular Disorders | Device: Aspiration Catheter Device: Solitaire FR | Not Applicable |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Aspiration Catheter
Mechanical thrombectomy with Aspiration Catheter.
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Device: Aspiration Catheter
Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management. |
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Active Comparator: Stent Retriever (Solitaire FR)
Mechanical thrombectomy with Solitaire FR.
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Device: Solitaire FR
Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management. |
- Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure [ Time Frame: immediate ]
- Proportion of functional independence (mRS 0-2) at 90 days [ Time Frame: 90 days ]
- Ordinal shift analysis of mRS at 90 days [ Time Frame: 90 days ]
- Instant recanalization rate (mTICI 2b-3) after the first thrombectomy [ Time Frame: immediate ]
- Instant recanalization rate (mTICI 2b-3) after the last thrombectomy [ Time Frame: immediate ]
- Procedure time (randomization to recanalization) [ Time Frame: procedure ]
- Change in NIHSS score at 24±2 hours [ Time Frame: 24 hours ]
- Change in NIHSS score at 7±1 days or discharge (whichever comes first) [ Time Frame: 7 days ]
- mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours [ Time Frame: 22-36 hours ]
- The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI [ Time Frame: 22-36 hours ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
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
| Contact: Zhongrong Miao, MD | 86-010-67098857 | 13601243293@163.com | |
| Contact: Yan Lin, Master | 86-13911573513 | yan.lin@hemochina.com |
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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 |
| Other Study ID Numbers: |
HEMO-CS1802 |
| First Posted: | November 26, 2018 Key Record Dates |
| Last Update Posted: | September 19, 2019 |
| Last Verified: | September 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Large vessel occlusion Acute ischemic stroke Endovascular treatment Mechanical thrombectomy Aspiration Catheter |
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Stroke Ischemic 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 Infarction Necrosis Embolism and Thrombosis Intracranial Embolism and Thrombosis Thromboembolism |