Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)

NCT03387995 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4157

Last updated 2024-09-23

No results posted yet for this study

Summary

Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to 25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular embolization is one of the main treatment ways of IA.However,there are no studies on the multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of IA.The investigators also study the relationship between cyclin dependent kinase inhibitor 2B antisense RNA 1 gene(CDKN2BAS1 gene)of IA patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of IA patients, providing theory gist for interventional therapy of complex IA and simplying slection of stent.

Conditions

  • Treatment Outcome by Stent-assisted Embolization

Interventions

DEVICE

LVIS stent

The paitents treated by LVIS stent implantation.

DEVICE

Solitaire stent

The paitents treated by Solitaire stent implantation.

DEVICE

Enterprise stent

The paitents treated by Enterprise stent implantation.

DEVICE

Neuroform stent

The paitents treated by Neuroform stent implantation.

DEVICE

Flow diverter (FD) stent

The paitents treated by Enterprise FD implantation.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Guangdong Provincial People's Hospital

    collaborator OTHER
  • Beijing Tiantan Hospital

    collaborator OTHER
  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • The Affiliated Hospital Of Southwest Medical University

    collaborator OTHER
  • Guangdong 999 Brain Hospital

    collaborator OTHER
  • Eighth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER
  • Zhujiang Hospital

    lead OTHER

Principal Investigators

  • Chuanzhi Duan, Ph.D. · Department of Neurosurgery, Zhujiang Hospital,Southern Medical University

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2023-12-30
Completion
2024-08-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387995 on ClinicalTrials.gov