Intracranial Artery Occlusion With Infarction (Disorder)NCT04840719
RECO in the Endovascular Treatment of Acute Ischemic Stroke
An observational study of Intracranial Artery Occlusion With Infarction (Disorder), run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Artery Occlusion With Infarction (Disorder)
- What is being tested?
- RECO
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2020to 30 Jul 2022
- Phase
- Observational
- 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
Study population: Patients with acute ischemic stroke caused by large vessel occlusion and using RECO to receive endovascular treatment.
Who may be able to join
- Age ≥ 18 years old
- Diagnosis of acute ischemic stroke
- Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT ≥ 6
- Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting
- The patient or the patient's legal representative is able and willing to sign the informed consent
Who cannot join
- Isolated cervical ICA or VA occlusion;
- No evidence of LVO on DSA.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010
Zhongrong Miao
About this study
Official title: A Prospective ,Multicenter, Registry Study of RECO in the Endovascular Treatment of Acute Ischemic Stroke
Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.
Read the detailed description
Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The Registry was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, to investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.
- Being tested
- RECO
- Keywords
- Acute ischemic stroke, endovascular treatment, registry
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RECODevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence at 90 days (modified Rankin Scale of 0-2)
The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.
Measured: [90±7 days after procedure]
Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure
Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration
Measured: 12-36 hours after the procedure
Time from symptom onset to recanalization
Minutes
Measured: From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours
Secondary outcomes (14)
Recanalization rate at the end of the procedure
modified thrombolysis in cerebral infarction (mTICI) 2b-3
Measured: Immediately after the procedure
Recanalization rate after the first attempt
mTICI score 2b-3
Measured: Immediately after the first attempt of endovascular treatment
Changes in NIHSS score immediately after the procedure
difference between NIHSS score immediately after the procedure and baseline
Measured: within 2 hours after the procedure
Changes in NIHSS score 24 hours after the procedure
difference between NIHSS score 24 hours after the procedure and baseline
Measured: 24 hours after the procedure
Changes in NIHSS score 7 days after the procedure or at discharge
difference between NIHSS score 7 days after the procedure or discharge and baseline
Measured: 7 days after the procedure or discharge
EQ-5D 90 days after the procedure
EQ-5D is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).A higher score indicates a better outcome.
Measured: 90±7 days after the procedure
Barthel index (BI) 90 days after the procedure
The BI has a score of 0-100. A higher score indicates a better outcome.
Measured: 90±7 days after the procedure
Parenchymal hematoma (PH2)
PH2 is defined as the rate of hematoma >30percent in infarct area
Measured: 12-36 hours after the procedure
Any intracranial hemorrhage on imaging
Based on the image
Measured: 12-36 hours after the procedure
All-cause mortality within 90 days
mortality
Measured: 90±7 days after the procedure
Time from onset to arrival
record the time
Measured: At baseline, after arrival at the hospital immediately
Time from arrival to imaging
record the time
Measured: At baseline, after taking any brain imaging immediately
Time from imaging to puncture
record the time
Measured: At baseline, during the procedure, after successful groin puncture immediately
Time from puncture to recanalization
record the time
Measured: At baseline, during the procedure, after successful recanalization immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start22 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Artery Occlusion With Infarction (Disorder)Studies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhongrong Miao, Beijing Tiantan Hospital
- Investigators
- Zhongrong Miao, PhD,MD, Principal investigator, Capital Medical University, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840719
- Sponsor's protocol ID
- KY 2019-080-03
- Status last verified
- Apr 2021
- First submitted
- 6 Nov 2020
- Last updated
- 14 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ding Y, Zhai T, Chen R, Chen F, Cheng Y, Zhu S, Liu Y, Xiao G, Zhang Y, Liu Y, Miao Z, Niu J. A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke. Sci Rep. 2024 Jan 25;14(1):2196. doi: 10.1038/s41598-024-52207-z.
PubMed 38272958
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective ,Multicenter, Registry Study of RECO in the Endovascular Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04840719
- Acronym / sponsor ID
- KY 2019-080-03
- Keywords
- Acute ischemic stroke, endovascular treatment, registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 22 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 12 Apr 2021 (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.
Investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.
Detailed description
Endovascular thrombectomy (EVT) is effective and safe for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) in major clinical trials. Whether the benefit of EVT in randomized trials could be generalized to clinical practice, especially in developing countries, remains unknown. The Registry was established to evaluate the utilization, and subsequent outcomes of EVT treated AIS patients. This study is a multi-center, prospective registry study initiated by researchers, to investigate Reco ® ,the first clot retriever in china as the primary therapyand remedies in the real world.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke caused by large vessel occlusion and using RECO to receive endovascular treatment.
Key inclusion criteria (5 listed)
- Age ≥ 18 years old
- Diagnosis of acute ischemic stroke
- Imaging confirmed intracranial large artery occlusion (LVO): intracranial internal carotid artery (ICA T/L), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);ASPECT or PC-ASPECT ≥ 6
- Initiation of any type of endovascular treatment (EVT), including intra-arterial thrombolysis, mechanical thrombectomy, angioplasty, and stenting
- The patient or the patient's legal representative is able and willing to sign the informed consent
Key exclusion criteria (2 listed)
- Isolated cervical ICA or VA occlusion;
- No evidence of LVO on DSA.
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 |
|---|---|---|
| RECO | Device | – |
Primary outcome
Functional independence at 90 days (modified Rankin Scale of 0-2)
Time frame: [90±7 days after procedure]
The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.
Symptomatic intracranial hemorrhage (sICH) within 12-36 hours after the procedure
Time frame: 12-36 hours after the procedure
Heidelberg Bleeding Classification): new intracranial hemorrhage detected by brain imaging associated with ≥4 points total National Institutes of Health Stroke Scale (NIHSS), ≥2 points in one NIHSS category, leading to intubation/ hemicraniectomy/ EVD placement or other major medical/surgical intervention, or absence of alternative explanation for deterioration
Time from symptom onset to recanalization
Time frame: From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours
Minutes
14 secondary outcomes
Recanalization rate at the end of the procedure
Time frame: Immediately after the procedure
Recanalization rate after the first attempt
Time frame: Immediately after the first attempt of endovascular treatment
Changes in NIHSS score immediately after the procedure
Time frame: within 2 hours after the procedure
Changes in NIHSS score 24 hours after the procedure
Time frame: 24 hours after the procedure
Changes in NIHSS score 7 days after the procedure or at discharge
Time frame: 7 days after the procedure or discharge
EQ-5D 90 days after the procedure
Time frame: 90±7 days after the procedure
Barthel index (BI) 90 days after the procedure
Time frame: 90±7 days after the procedure
Parenchymal hematoma (PH2)
Time frame: 12-36 hours after the procedure
Any intracranial hemorrhage on imaging
Time frame: 12-36 hours after the procedure
All-cause mortality within 90 days
Time frame: 90±7 days after the procedure
Time from onset to arrival
Time frame: At baseline, after arrival at the hospital immediately
Time from arrival to imaging
Time frame: At baseline, after taking any brain imaging immediately
Time from imaging to puncture
Time frame: At baseline, during the procedure, after successful groin puncture immediately
Time from puncture to recanalization
Time frame: At baseline, during the procedure, after successful recanalization immediately
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Derived from this study: PubMed 38272958Ding Y, Zhai T, Chen R, Chen F, Cheng Y, Zhu S, Liu Y, Xiao G, Zhang Y, Liu Y, Miao Z, Niu J. A prospective, multicentre, registry study of RECO in the endovascular treatment of acute ischaemic stroke. Sci Rep. 2024 Jan 25;14(1):2196. doi: 10.1038/s41598-024-52207-z.
- Individual participant dataSharing planned: No
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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.
Zhongrong Miao, PhD,MD principal investigator
Capital Medical University, Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Artery Occlusion With Infarction (Disorder), run by Beijing Tiantan Hospital 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 5 inclusion and 2 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 14 Apr 2021. 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 Baixue Jia, PhD,MD (86-010-67098857, beckyberry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence at 90 days (modified Rankin Scale of 0-2) (time frame: [90±7 days after procedure]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04840719, which also lists 1 linked publication.
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 14 Apr 2021.