Large Vessel OcclusionNCT03753061
Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)
A study testing Aspiration Catheter and Solitaire FR in people with Large Vessel Occlusion and Acute Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 23 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large Vessel Occlusion, Acute Ischemic Stroke, Cerebrovascular Disorders
- What is being tested?
- Aspiration Catheter and Solitaire FR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 23 sitesChina
- Study dates
- 22 Nov 2018to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites, 23 recruiting
- Recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
Zhiqiang Li
Zhiqiang Li
- Recruiting
Baotou Central Hospital
Baotou, Neimenggu, 014000
Changchun Jiang
Changchun Jiang
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Quanshan Ai
Quanshan Ai
- Recruiting
Beijing Luhe Hospital Medical University
Beijing, Beijing Municipality, 100000
Xiaokun Geng
Xiaokun Geng
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Zhongrong Miao, MD
Zhongrong Miao, MD
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Zhou Xing
Zhou Xing
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Wei Wu
Wei Wu
- Recruiting
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
Liyong Zhang
Liyong Zhang
- Recruiting
Luoyang Central Hospital
Luoyang, Henan, 471000
Liping Wei
Liping Wei
- Recruiting
Qingdao Central Hospital
Qingdao, Shandong, 266000
Haicheng Yuan
Haicheng Yuan
- Recruiting
Taihe Hospital
Shiyan, Hubei, 442000
Zhibing Ai
Zhibing Ai
- Recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000
Jin Zhang
Jin Zhang
- Recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063000
Yan Wang
Yan Wang
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300000
Binge Chang
Binge Chang
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300000
Li Yang
Li Yang
- Recruiting
Weihai Central Hospital
Weihai, Shandong, 264400
Hongjun Hou
Hongjun Hou
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710000
Zhenwei Zhao
Zhenwei Zhao
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Jianfeng Han
Jianfeng Han
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Xinchun Ye
Xinchun Ye
- Recruiting
Yantaishan Hospital
Yantai, Shandong, 264000
Dianjing Sun
Dianjing Sun
- Recruiting
Henan Province People's Hospital
Zhengzhou, Henan, 450000
Tianxiao Li
Tianxiao Li
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Sheng Guan
Sheng Guan
- Recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
Haibo Wang
Haibo Wang
About this study
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
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.
Read the 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.
- Being tested
- Aspiration Catheter, Solitaire FR
- Keywords
- Large vessel occlusion, Acute ischemic stroke, Endovascular treatment, Mechanical thrombectomy, Aspiration Catheter
- Medical subject headings
- Ischemic Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration CatheterDevice
Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.
Solitaire FRDevice
Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
| Study group | Role | What they receive |
|---|---|---|
| Aspiration Catheter | Experimental | Mechanical thrombectomy with Aspiration Catheter. Receives: Device: Aspiration Catheter |
| Stent Retriever (Solitaire FR) | Active comparator | Mechanical thrombectomy with Solitaire FR. Receives: Device: Solitaire FR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
Measured: immediate
Secondary outcomes (9)
Proportion of functional independence (mRS 0-2) at 90 days
Measured: 90 days
Ordinal shift analysis of mRS at 90 days
Measured: 90 days
Instant recanalization rate (mTICI 2b-3) after the first thrombectomy
Measured: immediate
Instant recanalization rate (mTICI 2b-3) after the last thrombectomy
Measured: immediate
Procedure time (randomization to recanalization)
Measured: procedure
Change in NIHSS score at 24±2 hours
Measured: 24 hours
Change in NIHSS score at 7±1 days or discharge (whichever comes first)
Measured: 7 days
mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours
Measured: 22-36 hours
The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI
Measured: 22-36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start22 Nov 2018
- Primary completion20 Mar 2020 (estimated)
- Study completion20 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753061
- Sponsor's protocol ID
- HEMO-CS1802
- Status last verified
- Sep 2019
- First submitted
- 21 Nov 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03753061
- Acronym / sponsor ID
- HEMO-CS1802
- Keywords
- Large vessel occlusion, Acute ischemic stroke, Endovascular treatment, Mechanical thrombectomy, Aspiration Catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology of the People´s Republic of ChinaOther government
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 20 Mar 2020 (estimated)
- Study completion
- 20 Mar 2020 (estimated)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspiration Catheter | Experimental | Device: Aspiration CatheterMechanical thrombectomy with Aspiration Catheter. |
| Stent Retriever (Solitaire FR) | Active comparator | Device: Solitaire FRMechanical thrombectomy with Solitaire FR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspiration CatheterPatients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management. | Device | Aspiration Catheter |
| Solitaire FRPatients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management. | Device | Stent Retriever (Solitaire FR) |
Primary outcome
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure
Time frame: immediate
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration Catheter and Solitaire FR in people with Large Vessel Occlusion and Acute Ischemic Stroke, run by Ministry of Science and Technology of the People´s Republic of China at 23 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongrong Miao, MD (86-010-67098857, 13601243293@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.