Aneurysm, Intracranial, Efficacy, Self, Hemodynamic Instability, Stenosis
Conditions
Keywords
intracranial aneurysms, flow-diverter device, Pipeline embolization device, in-stent stenosis
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.
Interventions
DEVICEPipeline 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.
Sponsors
Nanfang Hospital, Southern Medical University
Eighth Affiliated Hospital, Sun Yat-sen University
Zhongshan Hospital Of Traditional Chinese Medicine
First Affiliated Hospital of Jinan University
Beijing Tiantan Hospital
First Affiliated Hospital of Chongqing Medical University
Affiliated Hospital of Southwest Medical University
Guangdong 999 Brain Hospital
Shantou Central Hospital
Guangdong Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Harbin Medical University
Zhujiang Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 22 to 75 years old, male or non-pregnant female; 2. UIA was diagnosed by CTA, MRA, or DSA; 3. The size of aneurysms is between 3 to 25mm; 4. Understands the nature of the procedure and provision of written informed consent; 5. Indications for FD implantation with or without adjunctive coiling; 6. Is willing to return to the investigational site for follow-up according to our protocol.
Exclusion criteria
1. With contraindications to flow-diversion treatment or known allergy to cobalt-chromium alloy or contrast medium; 2. Pregnancy or lactation; 3. Coexist with other vascular lesions (coronary artery disease, abdominal aortic aneurysm, severe intracranial artery stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.); 4. Parent vessel with a diameter \<2.0 mm or ≥5.0 mm.; 5. Unwilling to be followed up or likely to have poor treatment compliance; 6. Life expectancy less than 3 years; 7. Inability to receive anti-platelet or anticoagulant medication; 8. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4); 9. Enrollment in another trial or other situations that the researcher deems unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactChuanzhi Duan, MD
Backup ContactXin Feng, MD
Outcome results
None listed