Intracranial Aneurysms
Conditions
Interventions
Tubridge Treatment Group:Treat intracranial aneurysms using Tubridge
Sponsors
People Hospital of Henan Province
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients understand the purpose and requirements of the study, can make him/herself understood, and has provided informed consent; 2. Male or Unpregnant female over 18 years of age; 3. Patients with unruptured aneurysms of the internal carotid artery or vertebral artery diagnosed by CTA, MRA or DSA (including saccular aneurysms, fusiform aneurysms, dissecting aneurysms), with the neck <= 20 mm; 4. Patients whom researchers believed that FD devices can be used to treat with; 5. Patients are willing and able to return for all follow-up visits required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with stents and/or coils placed in to treat the target IA within 3 months; 2. Ruptured aneurysms; 3. Patients who had and/or planned primary operations within 30 days; 4. AVM-related aneurysms; 5. Patients whom researchers believe not suitable for interventional therapy, such as: (1) No suitable vessel access; (2) Possibility of aortic dissection; (3) Possibility of intracranial vasculitis; (4) Extreme tortuosity of intracranial vessels; (5) Severe vascular stenosis or incomplete stent apposition prevents the device from the successful deployment; (6) Patients with previous vasospasm and poor antispasmodic efficacy refractory to medications or other measurements.; 6.Patients contraindicated for Tubridge Vascular Reconstruction Device: (1) Patients with contraindication of antiplatelet or anticoagulant therapy (2) Patients with contraindication of DSA: a. iodine contrast agent allergy or intolerance; b. interventional equipment allergy; c. severe heart, liver and kidney insufficiency; d. local infection of puncture point; e. concurrent cerebral hernia; (3) Patients allergic to nickel-titanium alloy materials (4) Evidence of active infection at the time of treatment (body temperature > 38 degrees C and/or white blood cell count > 15 * 10^9/L) 7. Participating in another clinical trial; 8. The clinical condition was in inferior quality.; 9. The modified Rankin scale (mRS) score >= 5; 10. Patients whose life expectancy is less than 12 months; 11. Women who are pregnant, breastfeeding, or planning to pregnant during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of target aneurysm evaluated with Raymond Roy Grade I (100%) occlusion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate technique success rate;significant pParent artery stenosis (=50%);Successful occlusion rate of target IA (Raymond- I & ?);Recurrence rate and retreatment rate of target aneurysm;modified Rankin Scale (mRS);Target aneurysm-related mobidity and mortality;All-cause mortality; | — |
Countries
China
Contacts
Public ContactTianxiao Li
He'nan People's Hospital
Outcome results
None listed