About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 22 to 75 years old, male or non-pregnant female;
UIA was diagnosed by CTA, MRA, or DSA;
The size of aneurysms is between 3 to 25mm;
Understands the nature of the procedure and provision of written informed consent;
Disqualifiers
With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium;
Pregnancy or lactation;
Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
Parent vessel with a diameter <2.0 mm or ≥5.0 mm.;
Trial population
Patients underwent Pipeline implantation for intracranial aneurysms
Trial design
Cohort
Prospective
Treatments tested in this trial
Pipeline embolization device with or without shield technique
DeviceThe patients undenwent Pipeline embolization device implantation with or without shield technique due to market availability, choice and preferences of the surgeon.
Treatment groups
Trial outcomes
Primary outcomes
The 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).
Secondary outcomes
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 %)
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zhujiang Hospital
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Beijing Tiantan Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Affiliated Hospital of Southwest Medical University
Collaborator
Guangdong 999 Brain Hospital
Collaborator
Shantou Central Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator