StrokeNCT05667103
The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients
A study testing Embotrap stent retriever and Solitaire FR, Trevo stent retriever without inner channel in people with Stroke and Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute Ischemic Stroke
- What is being tested?
- Embotrap stent retriever and Solitaire FR, Trevo stent retriever without inner channel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 1 Jul 2024
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.
- Premorbid mRS 0-2
- Ages 18-80 years
- NIHSS ≥6 at admission
- The time from onset to groin puncture ≤ 24 hours
- ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP)
- Informed consent approved by patients or acceptable patient surrogate.
Who cannot join
- Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory).
- Severe allergy to contrast media allergy and nitinol
- Refractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
- Platelet count < 30 x 10^9 / L
- Coagulopathy history or hemorrhage disorders disease
- Concurrent participation in a study involving an investigational drug or device that would impact the current study
Show all 12Show fewer
- Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy
- Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders
- Pregnant or lactating women
- Anticipated life expectancy < 6 months
- Patients without a legally authorized representative to sign the consent form
- For other reasons, the researchers believe that the patient is not suitable for enrollment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University.
Beijing, 100053
Liqun Jiao, Dr., 13911224991, liqunjiao@sina.cn
About this study
Official title: The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients
This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.
Read the detailed description
AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, Embotrap stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap stent retriever was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap stent retriever with other stent retrievers without inner channel.
- Conditions
- Stroke, Acute Ischemic Stroke
- Being tested
- Embotrap stent retriever, Solitaire FR, Trevo stent retriever without inner channel
- Keywords
- Embotrap, Acute ischemic stroke, Mechanical thrombectomy, Stent retriever
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embotrap stent retrieverDevice
Embotrap has a novel design of an open outer cage for clot capture and a closed inner channel for clot stabilization, with great thrombus fixation and anti-escape ability, to improve the successful recanalization rate and good prognosis of patients.
Solitaire FR, Trevo stent retriever without inner channelDevice
Other stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or NMPA.
| Study group | Role | What they receive |
|---|---|---|
| Embotrap stent retriever | Experimental | Not described Receives: Device: Embotrap stent retriever |
| Other stent retriever without endochannel | Active comparator | Not described Receives: Device: Solitaire FR, Trevo stent retriever without inner channel |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-pass complete recanalization rate
FPE, eTICI≥2c
Measured: intraoperative (After first-pass thrombectomy)
Secondary outcomes (8)
First-pass successful recanalization rate
mFPE, eTICI≥2b50
Measured: intraoperative (After first-pass thrombectomy)
Final successful recanalization rate
mFPE, eTICI≥2b50
Measured: intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
Final complete recanalization rate
FPE, eTICI≥2c
Measured: intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
90-day favorable outcome rate
Modified Rankin scale (mRS), the scale runs from 0 to 6, running from perfect health without symptoms to death. 90-day favorable outcome is identified as mRS 0-2.
Measured: 90-days (±14days)
The improvement of the NIHSS scores 24 hours after surgery
National Institutes of Health Stroke Scale (NIHSS)
Measured: 24 hours after surgery
The improvement of the NIHSS scores 5-7 days after surgery or at discharge
National Institutes of Health Stroke Scale (NIHSS)
Measured: 5-7 days after surgery or at discharge, whichever came first
The rescue therapy rate
The rate of rescue therapy, such as balloon dilation, stent implantation, and intra-arterial thrombolysis.
Measured: During procedure time
FFR after 5 minutes of mechanical thrombectomy
Fractional flow reserve (FFR)
Measured: 5 minutes after successful vessel recanalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start15 Jan 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Model description
- This study is a multicenter, parallel cohort study. The patients with acute middle cerebral artery occlusion were divided into Embotrap group and control group at a ratio of 1:1 to receive mechanical thrombectomy. The patients in control group will receive thrombectomy using stent retriever without inner channel approved by FDA or NMPA. Several aspects such as first-pass recanalization rate, the successful recanalization rate, and mRS score at 90 days will be compared between the two groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liqun Jiao, Dr., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667103
- Sponsor's protocol ID
- Embotrap
- Status last verified
- Nov 2022
- First submitted
- 21 Nov 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Mechanical Thrombectomy Using Embotrap Stent Retriever in Treating Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05667103
- Acronym / sponsor ID
- Embotrap
- Conditions
- Stroke, Acute Ischemic Stroke
- Keywords
- Embotrap, Acute ischemic stroke, Mechanical thrombectomy, Stent retriever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 28 Dec 2022 (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 is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.
Detailed description
AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, Embotrap stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap stent retriever was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap stent retriever with other stent retrievers without inner channel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a multicenter, parallel cohort study. The patients with acute middle cerebral artery occlusion were divided into Embotrap group and control group at a ratio of 1:1 to receive mechanical thrombectomy. The patients in control group will receive thrombectomy using stent retriever without inner channel approved by FDA or NMPA. Several aspects such as first-pass recanalization rate, the successful recanalization rate, and mRS score at 90 days will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Embotrap stent retriever | Experimental | Device: Embotrap stent retriever |
| Other stent retriever without endochannel | Active comparator | Device: Solitaire FR, Trevo stent retriever without inner channel |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.
- Premorbid mRS 0-2
- Ages 18-80 years
- NIHSS ≥6 at admission
- The time from onset to groin puncture ≤ 24 hours
Key exclusion criteria (12 listed)
- Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory).
- Severe allergy to contrast media allergy and nitinol
- Refractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg)
- Platelet count < 30 x 10^9 / L
- Coagulopathy history or hemorrhage disorders disease
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 |
|---|---|---|
| Embotrap stent retrieverEmbotrap has a novel design of an open outer cage for clot capture and a closed inner channel for clot stabilization, with great thrombus fixation and anti-escape ability, to improve the successful recanalization rate and good prognosis of patients. | Device | Embotrap stent retriever |
| Solitaire FR, Trevo stent retriever without inner channelOther stent retriever without inner channel, such as Solitaire FR, Trevo, and other stent retrievers approved by FDA or NMPA. | Device | Other stent retriever without endochannel |
Primary outcome
First-pass complete recanalization rate
Time frame: intraoperative (After first-pass thrombectomy)
FPE, eTICI≥2c
8 secondary outcomes
First-pass successful recanalization rate
Time frame: intraoperative (After first-pass thrombectomy)
Final successful recanalization rate
Time frame: intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
Final complete recanalization rate
Time frame: intraoperative (Final Digital Subtraction Angiography (DSA) during operation)
90-day favorable outcome rate
Time frame: 90-days (±14days)
The improvement of the NIHSS scores 24 hours after surgery
Time frame: 24 hours after surgery
The improvement of the NIHSS scores 5-7 days after surgery or at discharge
Time frame: 5-7 days after surgery or at discharge, whichever came first
The rescue therapy rate
Time frame: During procedure time
FFR after 5 minutes of mechanical thrombectomy
Time frame: 5 minutes after successful vessel recanalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
Liqun Jiao, Dr. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embotrap stent retriever and Solitaire FR, Trevo stent retriever without inner channel in people with Stroke and Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site 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 12 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Liqun Jiao, Dr. (13911224991, liqunjiao@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-pass complete recanalization rate (time frame: intraoperative (After first-pass thrombectomy)). 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 13 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.