NCT06446778

Pipeline Embolization for Intracranial Aneurysms

Pipeline Embolization Device for Intracranial Aneurysm (PEDIA): a Prospective, Multicenter Cohort Focus on Safety, Efficacy, and Haemodynamics

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization.

Detailed description

This study collected the clinical, laboratory, and imaging data from patients with intracranial aneurysms, who underwent Pipeline implantation. The purpose of this study is to observe the safety, effcacy, and haemodynamics after Pipeline embolization. The primary outcomes were aneurysmal occlusion status, incidence of in-stent stenosis, and functional prognosis. The secondary outcomes were hemodynamic changes before and after stent implantation.

Conditions

• Efficacy, Self
• Hemodynamic Instability
• Stenosis
• Aneurysm, Intracranial

Interventions

Type	Name	Description
DEVICE	Pipeline embolization device with or without shield technique	The patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon.

Timeline

• Start date: 2022-09-01
• Primary completion: 2027-09-01
• Completion: 2030-09-01
• First posted: 2024-06-06
• Last updated: 2024-11-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study