intracranial aneurysm
Conditions
Interventions
Tubridge FDs treatment group:NA
Sponsors
Cerebrovascular Disease Center of Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-75 years, male or non-pregnant female; 2) IA (intracranial aneurysm) confirmed by CTA, MRA or DSA; and suitable for endovascular intervention 3) IA size between 3-25mm; 4) The patient and/or his/her legal representative or guardian understand the purpose of the study, voluntarily participate and sign the informed consent form; 5) Patients who the investigator believes can be treated with FD; 6) Patients who are willing to undergo follow-up evaluation in accordance with the requirements of the clinical research protocol.
Exclusion criteria
Exclusion criteria: 1) Patients who have placed a stent or spring coil at the lesion within three months; 2) patients with ruptured IA; 3) Patients who have had or plan to have major surgery within 30 days; 4) AVM (arteriovenous malformation), moyamoya disease or DAVF (dural arteriovenous fistula) related aneurysm; 5) Patients who the investigator considers unsuitable for vascular intervention, such as: A. No suitable vascular approach or path vascular tortuousness; B. Intracranial vasculitis possible; C. Severe stenosis of the current-carrying aneurysm, resulting in difficulty in stent placement or extremely high surgical risk; 6) Patients with contraindications to Tubridge flow diverters: A. Patients with contraindications to antiplatelet or anticoagulant therapy; Patients with contraindications to B. DSA: a. Iodine contrast agent allergy or intolerance; b. Allergy to interventional equipment; c. Severe cardiac, hepatic and renal insufficiency; d. Local infection at the puncture site; e. Concurrent cerebral herniation; C. Patients allergic to nitinol; D. Patients in the active infection phase (body temperature higher than 38 ° C or white blood cell count > 15 * 109 / L). 7) Those who are participating in clinical trials of other drugs or medical devices; 8) Patients with serious underlying diseases, extremely poor clinical condition, and unable to tolerate general anesthesia surgery; 9) Patients with poor compliance and unable to cooperate with follow-up; 10) contraindications to dual antiplatelet therapy and anticoagulant therapy; 11) a possible or definite history of severe allergy to contrast media; 12) Patients with a life expectancy of less than 2 years; 13) Women who are breastfeeding and trying to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS score 12 months postoperatively;Aneurysm occlusion rate at 12 months postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| mRS score 30 days postoperatively;Tubridge Flow Diverters Surgical Success Rate;Device-related neurological adverse events;Major adverse events 30 days after surgery;Aneurysm rebleeding or retreatment rate at 12 months postoperatively;Rate of stenosis or blockage within the stent at 12 months postoperatively;Intracranial ischemia, bleeding and other adverse events within 12 months postoperatively; | — |
Countries
China
Contacts
Public ContactDuan Chuanzhi
Cerebrovascular Disease Center of Zhujiang Hospital of Southern Medical University
Outcome results
None listed