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

NCT05166733 | Unknown

• 1 other identifier: 2021（ke）CL274
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neurology; Interventional Therapy

Keywords

ischemic stroke; Reco; endovascular treatment

Outcome Measures

Primary Outcomes (3)

• The time between the onset of the disease and the opening of the blood vessels

  Calculate the time from onset to vessel opening

  Immediately after surgery

• Functional independence at 90 days (defined as mRS≤2)

  mRS scores were performed 90 days after surgery

  90day after surgery

• Symptomatic intracranial hemorrhage within 24 hours after surgery

  Symptomatic intracranial hemorrhage was evaluated by CT 24 hours after operation

  24 hours after surgery

Secondary Outcomes (3)

• Time from onset to admission

  Immediately after surgery

• Time from admission and puncture time

  Immediately after surgery

• Puncture to the time of vessel opening

  Immediately after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing endovascular treatment for acute ischemic stroke with the Reco Embolectomy Stent from December 2018 to June 2021.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PengYa: lead
• Jingjiang People's Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• The Second Hospital of Nanjing Medical University: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Yixing People's Hospital: collaborator

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jie Cao

CONTACT

13646125766; mayday509@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 22, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)