Intracranial aneurysm
Conditions
Interventions
Treatment group:Flow diverting coated dense-mesh stent
Sponsors
The First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Age 18-80 years(included); 2) Imaging (DSA) confirmed the presence of a single unruptured intracranial aneurysm (IA) requiring treatment with the following features: a) The circle of Willis and its distal to M1 bifurcation anterior segment of middle cerebral artery (MCA), segment A1-A2 of anterior cerebral artery (ACA), terminal segment of internal carotid artery (ICA), posterior communicating artery (Pcom) or segment P1-P2 of posterior cerebral artery (PCA); b) Wide-neck aneurysm with an aneurysm neck =4 mm or a body-to-neck ratio of aneurysm <2, or fusiform aneurysm; 3) The vessel diameter for device implanting was 1.5-7.0 mm; 4) Voluntarily sign the informed consent form and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) The location, shape and size of aneurysms did not meet the requirements of the study: a) The presence of two or more aneurysms requiring treatment; b) There are branching vessels originating from the aneurysm; c) The aneurysm was located in the posterior communicating artery with embryonal posterior cerebral artery; d) The aneurysm was located at the bifurcation of an artery; e) Patients lacked 3D aneurysm images or images did not meet the simulation requirements; f) Ruptured aneurysm, dissecting aneurysm or blood blister-like aneurysm; 2) Major surgical operations were planned to be performed within 30 days prior to enrollment or within 120 days after surgery as judged by the investigator; 3) Patients with subarachnoid hemorrhage, cerebral hemorrhage and cerebral infarction within 30 days before surgery; 4) Patients with severe intracranial vascular tortuosity or stenosis identified by preoperative imaging, or a history of intracranial vasospasm, no response to drug therapy and whose anatomical structure is not suitable for endovascular therapy; 5) The patient had an unhealed bleeding disorder or active bleeding; 6) There are contraindications associated with flow diverting dense-mesh stent therapy; a) Allergic to anticoagulant and antiplatelet drugs, local or general anesthetic drugs, or contrast media during the procedure; b) A known severe allergy to nickel, chromium, cobalt, tungsten or platinum; c) Patients with active infection who are not suitable for surgery as judged by the investigator (such as fever, temperature > 38°C and/or leukocyte >15×109/L); d) A known coagulation disorder or ongoing chronic anticoagulation therapy; e) A stent is present in the parent artery. 7) Modified Rankin score=4 points before operation; 8) Patients with unstable neurological deficits or neurodegenerative diseases who were not suitable for surgery as judged by the investigator; 9) Other known serious disorders as judged by the investigator, such as severe cardiac disease, myocardial infarction within 12 weeks prior to enrollment, symptomatic congestive heart failure or carotid artery stenosis, renal failure (serum creatinine >2.0mg/dl), severe atherosclerosis or atherosclerotic thrombotic occlusive disease, ischemic stroke or high-risk population with recent stroke, or hematopoietic disease; 10) Intracranial mass (tumor, meningioma, etc.); 11) Patients with untreated arteriovenous malformation (AVM); 12) Patients who have participated in other clinical trials of medical devices or drugs during the same period; 13) women who are pregnant or lactation; 14) Other conditions deemed inappropriate by the investigator to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm complete occlusion rate 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate;Aneurysm complete occlusion rate 6 months after surgery;Aneurysm success occlusion rate 12 months after surgery;mRS Scores improving 6 months and 12 months after surgery;Stroke or neurogenic death rate within 30 days after surgery in the area of the parent artery;Delayed cerebral hemorrhage rate within 12 months after surgery (more than 30 days after surgery);In-stent stenosis (>50% stenosis) rate 12 months after surgery;In-stent thrombosis rate 12 months after surgery; | — |
Countries
China
Contacts
Public ContactJianmin Liu
The First Affiliated Hospital of Naval Medical University
Outcome results
None listed