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.
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 Type
OBSERVATIONAL
Enrollment
1,000
The patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon.
Zhujiang hospital
Guangzhou, Guangdong, China
RECRUITINGThe occlusion rate of the aneurysm
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).
Time frame: 1 years
in-stent stenosis
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 %)
Time frame: 1 years
perioperative complications
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.
Time frame: 1 months
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