A Multicenter, Single-arm, Confirmatory Study to Assess the Safety and Efficacy of Intracranial Cerebral Aneurysm Embolization with G-009
- Conditions
- nruptured cerebral aneurysmCerebral AneurysmD002532
- Registration Number
- JPRN-jRCT2052210121
- Lead Sponsor
- eno Junji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 39
1) Has a single unruptured aneurysm located in the internal carotid artery, intradural vertebral artery, or basilar artery that requires treatment.
2) The aneurysm is difficult to treat with conventional surgical treatment.
3) Has an aneurysm with any of the following morphologies:
- Wide-neck aneurysm with a maximum diameter of 10mm or more
- Aneurysm with a maximum diameter of 5 mm or more and less than 10 mm, which is likely to recur with conventional treatments (cerebral aneurysm coil embolization, stent-assisted coil embolization)
- Spindle-shaped aneurysm
4) Has a degree of independence in the daily life corresponding to modified Rankin Scale 3 or less.
5) Provided voluntary written consent to participate in this clinical trial.
6) Is willing to perform follow-up visits at 30 days, 90 days, 6 months, and 12 months after the procedure
7) Has a parent vessel into which the test device can be navigated.
1) Has an posterior circulation aneurysm with any of the following morphologies:
- The test device would be implanted across the basilar artery bifurcation
- Large or giant dolichoectatic aneurysm
2) The aneurysm is located at the bifurcation of the cerebral artery.
3) A major branch is located on the dome of the cerebral aneurysm.
4) Has another cerebral aneurysm, other than the target aneurysm, that needs to be treated simultaneously.
5) Has an anatomical structure that is not suitable for endovascular treatment (severe tortuosity, stenosis).
6) Has a mycotic or dissecting aneurysm.
7) Has a history of stent placement in the target aneurysm.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy:<br>Percentage of subjects with complete occlusion of the target aneurysm and a patent parent vessel (luminal stenosis rate 50% or less) as evaluated by angiography at 12 months who did not receive retreatment for the target aneurysm within 12 months after the procedure.<br><br>Safety:<br>Percentage of subjects who experienced the following events 1) or 2):<br>1) Death or major stroke within 30 days after the procedure<br>2) Cranial nerve-related death or ipsilateral major stroke within 12 months after the procedure
- Secondary Outcome Measures
Name Time Method