NeurologyNCT05166733
A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke
An observational study of Neurology and Interventional Therapy, run by PengYa at 1 site in China.
Trial summary
To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurology, Interventional Therapy
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2021to 31 Dec 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 undergoing endovascular treatment for acute ischemic stroke with the Reco Embolectomy Stent from December 2018 to June 2021.
Who may be able to join
- Patient age ≥18 years
- The clinical diagnosis was acute ischemic stroke
- Large vascular lesions were detected by head CT, CTA, MRI, MRA or DSA
- Preoperative baseline NIHSS score > 4
- MRS 0-1 before this stroke
- Mechanical thrombectomy was performed
- Use Reco thrombectomy bracket
Who cannot join
- epileptic seizure
- Sudden coma
- Neurological loss symptoms quickly improved
- Imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage
- Previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect)
- History of head trauma within 3 months prior to surgery
Show all 10Show fewer
- History of arterial puncture with difficulty in compression and hemostasis within one week prior to surgery
- Physical examination revealed evidence of active bleeding or trauma (e.g. fracture)
- Women are known to be pregnant or breastfeeding
- Severe allergies to contrast agents are known
Trial locations and contacts
1 site in 1 country.
About this study
To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. To investigate the use and embolectomy effect of Reco, the first embolectomy stent in China, in economically developed areas. Health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.
Read the detailed description
The Reco Embolectomy Stent is indicated for patients who cannot be treated with intravenous tissue activator (IVt-PA) or who have failed IVt-PA therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.
- Conditions
- Neurology, Interventional Therapy
- Keywords
- ischemic stroke, Reco, endovascular treatment
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
The time between the onset of the disease and the opening of the blood vessels
Calculate the time from onset to vessel opening
Measured: Immediately after surgery
Functional independence at 90 days (defined as mRS≤2)
mRS scores were performed 90 days after surgery
Measured: 90day after surgery
Symptomatic intracranial hemorrhage within 24 hours after surgery
Symptomatic intracranial hemorrhage was evaluated by CT 24 hours after operation
Measured: 24 hours after surgery
Secondary outcomes (3)
Time from onset to admission
Calculate the time from onset to admission
Measured: Immediately after surgery
Time from admission and puncture time
Calculate the time from onset to admission
Measured: Immediately after surgery
Puncture to the time of vessel opening
Calculate the time from puncture to vascular opening
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study startDec 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurologyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PengYa
- Sponsor type
- University, hospital or other
- Collaborators
- Jingjiang People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The Second Hospital of Nanjing Medical University, Northern Jiangsu People's Hospital, Yixing People's Hospital
- Responsible party
- Sponsor-investigator, PengYa, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166733
- Sponsor's protocol ID
- 2021（ke）CL274
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05166733
- Acronym / sponsor ID
- 2021（ke）CL274
- Conditions
- Neurology, Interventional Therapy
- Keywords
- ischemic stroke, Reco, endovascular treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- PengYaUniversity, hospital or other
- Collaborators
- Jingjiang People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The Second Hospital of Nanjing Medical University, Northern Jiangsu People's Hospital, Yixing People's Hospital
- Study start
- Dec 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Dec 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.
To explore the differences in the green channel process of stroke in various regions of the same province, to target and shorten the time delay of emergency process, and to explore the key technologies of endovascular treatment of acute ischemic stroke. To investigate the use and embolectomy effect of Reco, the first embolectomy stent in China, in economically developed areas. Health economic assessment (cost-benefit analysis) of ischemic stroke patients in various regions of the province.
Detailed description
The Reco Embolectomy Stent is indicated for patients who cannot be treated with intravenous tissue activator (IVt-PA) or who have failed IVt-PA therapy and is intended to remove thrombus from a large intracranial vessel in patients with ischemic stroke to restore blood flow.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing endovascular treatment for acute ischemic stroke with the Reco Embolectomy Stent from December 2018 to June 2021.
Key inclusion criteria (7 listed)
- Patient age ≥18 years
- The clinical diagnosis was acute ischemic stroke
- Large vascular lesions were detected by head CT, CTA, MRI, MRA or DSA
- Preoperative baseline NIHSS score > 4
- MRS 0-1 before this stroke
Key exclusion criteria (10 listed)
- epileptic seizure
- Sudden coma
- Neurological loss symptoms quickly improved
- Imaging was negative, but clinical symptoms did not rule out subarachnoid hemorrhage
- Previous intracranial hemorrhage, subarachnoid hemorrhage, and brain tumor (with mass effect)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The time between the onset of the disease and the opening of the blood vessels
Time frame: Immediately after surgery
Calculate the time from onset to vessel opening
Functional independence at 90 days (defined as mRS≤2)
Time frame: 90day after surgery
mRS scores were performed 90 days after surgery
Symptomatic intracranial hemorrhage within 24 hours after surgery
Time frame: 24 hours after surgery
Symptomatic intracranial hemorrhage was evaluated by CT 24 hours after operation
3 secondary outcomes
Time from onset to admission
Time frame: Immediately after surgery
Time from admission and puncture time
Time frame: Immediately after surgery
Puncture to the time of vessel opening
Time frame: Immediately after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- 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.
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 Neurology and Interventional Therapy, run by PengYa 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 10 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 22 Dec 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 Jie Cao (13646125766, mayday509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time between the onset of the disease and the opening of the blood vessels (time frame: Immediately after surgery). 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?
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 22 Dec 2021.