Pipeline Embolization for Intracranial Aneurysms

Recruiting

• Conditions: Aneurysm, Intracranial; Efficacy, Self; Hemodynamic Instability; Stenosis

• Registration Number: NCT06446778
• Lead Sponsor: Zhujiang Hospital

Brief 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.

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-06
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-18
• Primary Completion: 2027-09-01
• Study Completion: 2030-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occlusion rate of the aneurysm	1 years	The occlusion rate of the aneurysm at 6 months；O'Kelly Marotta classification: complete occlusion (D, entirely non-filling), near-complete occlusion (C, only entry remnant), and incomplete occlusion (A and B, subtotal and total filling).

Secondary Outcome Measures

Name	Time	Method
in-stent stenosis	1 years	In-stent stenosis is defined as a growth process beyond the limits of stent mesh, which appears as a visible gap between the vessel lumen filled with contrast agent and stent struts.; Stenosis ratio (SR) = \[1-(actual diameter of the most stenotic segment with digital subtraction/actual diameter of stent measured on without digital subtraction)\]\*100%; When there was no appreciable gap, cases were described as patency. Intimal hyperplasia was labeled when the SR was less than 25 %. ISS was defined as an SR of ≥ 25 %, and the stenosis grade was classified as mild (25 % to 49 %), severe (50 % to 99 %), or lumen occlusion (SR = 100 %)
perioperative complications	1 months	perioperative complications；such as arterial perforation, iatrogenic arterial dissection, embolization in previously uninvolved vascular territory, arterial access site hematoma, and retroperitoneal hematoma. Arterial perforation will be defined at angiography by the operator and associated with subarachnoid hemorrhage. Iatrogenic arterial dissection will be defined at angiography by the operator. Arterial access site hematoma will be assessed as a complication of arterial access puncture and defined by clinical examination and anatomic imaging. Retroperitoneal hematoma will be assessed as a complication of groin puncture and defined by imaging (ultrasound or CT or MR angiography). The definition of embolization in previously uninvolved vascular territory is noted after recanalization of the primary occlusion site, any vessel occlusions distal from the primary occlusion site are considered emboli due to periprocedural thrombus fragmentation.

Trial Locations

Locations (1)

Zhujiang hospital; 🇨🇳 Guangzhou, Guangdong, China