A Retrospective Study of Reco Thrombectomy Stent for Intravascular Treatment of Acute Ischemic Stroke

NCT ID: NCT05166733

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-12-31

Brief Summary

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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

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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

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Neurology Interventional Therapy

Keywords

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ischemic stroke Reco endovascular treatment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jingjiang People's Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Nanjing Medical University

OTHER

Sponsor Role collaborator

Northern Jiangsu People's Hospital

OTHER

Sponsor Role collaborator

Yixing People's Hospital

OTHER

Sponsor Role collaborator

PengYa

OTHER

Sponsor Role lead

Responsible Party

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PengYa

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Jie Cao

Role: CONTACT

Phone: 13646125766

Email: [email protected]

Facility Contacts

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Jie Cao

Role: primary

Other Identifiers

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2021(ke)CL274

Identifier Type: -

Identifier Source: org_study_id