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NCT06446778 Clinical Trial

Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms. Evaluation of the Safety and Efficacy of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms

Safety Issues Clinical Trial

Official title:
Haemodynamic Mechanisms and Multicentre Prospective Cohort Study of the Pipeline Flow-diverting Device for the Treatment of Intracranial Aneurysms.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06446778
Other study ID # LC2024ZD027
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date September 1, 2025

Study information
Verified date April 2024
Source Zhujiang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to collect clinical, laboratory, and imaging data from patients with unruptured intracranial aneurysms, and collect blood or urine samples for cotinine testing. The enrolled patients underwent Pipeline implantation. The purpose is to study the effect after Pipelineline implantation.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 1000
Est. completion date September 1, 2025
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18years Exclusion Criteria: - with other cerebrovascular disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhujiang hospital Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary incomplete occlusion incomplete occlusion 1 years
Secondary in-stent stenosis in-stent stenosis 1 years
Secondary perioperative complications perioperative complications 1 years
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