Intracranial Aneurysms
Conditions
Interventions
The Tubridge Group:Tubridge flow diverter alone or combined with bare coils
The Enterprise Group:Enterprise stent combined with bare coils
Sponsors
Department of Neurosurgery, Changhai Hospital, Second Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years old, male or non-pregnant female patients; 2. patients with unruptured carotid or vertebral artery aneurysms (including saccular or recanalized aneurysms)confirmed by CTA, MRA or DSA; 3. The diameter of the aneurysm neck should be no less than 4 mm and maximum diameter no less than 10mm; 4. The diameter of the parent artery should range from 2.0 mm to 6.5 mm; 5. The aneurysm is indicated for endovascular treatment using Tubridge flow diverter or Enterprise stent; 6. the patient is willing to be followed up in accordance with the study protocol; 7. The patients are able to understand the purpose of the trial, be voluntary to participate in this trial and have signed informed consent.
Exclusion criteria
Exclusion criteria: 1. there is no appropriate route for endovascular treatment; 2. Flow-related aneurysms due to arteriovenous malformation; 3. ruptured aneurysms; 4. The patients vasculature is unfavorable for delivering and deploying a stent. (such as too tortuous vasculature, stents can not be delivered to the lesion, there is in-stent stenosis or not fully expanded stent in the parent artery for recanalized aneurysms etc.); 5. scheduled surgery within 30 days; 6. poor clinical condition,modified Rankin score more than 4; 7. the patient's life expectancy is less than 12 months; 8. The patient has been enrolled into other ungoing trials about drugs or medical devices; 9. The patients' compliance is poor, and unable to complete the study in accordance with the protocol; 10. patients with history of being allergic to nickel titanium alloy; 11. The patient has contra-indications for anti-platelet or anticoagulantion therapy; 12. patients have been or might be allergic to contrast.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion rate at 6-month follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Death or stroke related to the target vessel at day 30, day 90, and one year after operation;Rupture of the aneurysm at day 30, day 90, and one year after operation;rate of in-stent stenosis 6 months after the process;rate of in-stent thrombosis 6 months after the operation;Rate of adverse events at day 30, day 90, and one year after operation;packing density of the aneurys; | — |
Countries
China
Contacts
Public ContactJanmin Liu
Outcome results
None listed