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A Multicenter, Single-arm, Confirmatory Study to Assess the Safety and Efficacy of Intracranial Cerebral Aneurysm Embolization with G-009 (G-009-P01)

A Multicenter, Single-arm, Confirmatory Study to Assess the Safety and Efficacy of Intracranial Cerebral Aneurysm Embolization with G-009 (G-009-P01)

Ueno Junji

GOODMAN CO., LTD.

5F Shinjuku 311Building, 3-11-10 Shinjuku, Shinjuku-ku, Tokyo, 160-0022, Japan

junji.ueno@goodmankk.com

Takahata Yusuke

GOODMAN CO., LTD.

5F Shinjuku 311Building, 3-11-10 Shinjuku, Shinjuku-ku, Tokyo, 160-0022, Japan

+81-3-5919-3229

yusuke.takahata@goodmankk.com

Not Recruiting

Nov. 12, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

Both

Unruptured cerebral aneurysm

At least two antiplatelets (aspirin, clopidogrel, cilostazol, ticlopidine, etc.) should be administered as pre-medication from 4 days or more before to the day of the index procedure.
The test device is placed at the target aneurysm for subjects who are judged to be eligible for registration.
For subjects in whom the test device was placed at the target aneurysm, at least two antiplatelets should be administered for a minimum of 12 weeks from the day following the index procedure. At least one antiplatelet should be continued until 12 months after the procedure.

Cerebral Aneurysm

Cerebral aneurysm embolization, Covered stent

D002532

D002532

Efficacy:
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.

Safety:
Percentage of subjects who experienced the following events 1) or 2):
1) Death or major stroke within 30 days after the procedure
2) Cranial nerve-related death or ipsilateral major stroke within 12 months after the procedure

Efficacy:
1) Percentage of subjects who have an occlusion of 90% or more with a patent parent vessel (luminal stenosis of 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.
2) Percentage of subjects who have an occlusion of 90% or more as evaluated by angiography at 12 months after the procedure.
3) Percentage of subjects who have a patent parent vessel (luminal stenosis rate 50% or less) as evaluated by angiography at 12 months after the procedure.
4) Percentage of subjects who did not receive retreatment for the target aneurysm within 12 months after the procedure.
5) Evaluation of the degree of embolization of the target aneurysm and changes over time at 6 months and 12 months after the procedure (to be completed in subjects who underwent angiography at 6 months after the procedure).
6) Technical success rate (percentage of subjects who had a stent placed in the parent vessel including the aneurysm neck and a patent parent vessel at the end of the procedure).
7) Incidence of stent migration at 12 months after the procedure.

Safety:
1) Incidence of cranial nerve-related death up to 12 months after the procedure.
2) Incidence of stroke or death up to 12 months after procedure.
3) Percentage of subjects with a higher mRS score on neurological evaluation at 6 months and at 12 months after the procedure (as compared to the baseline).
4) Incidence of serious adverse events for which a causal relationship with the test device or procedure cannot be ruled out.
5) Incidence of device failures.

+81-6-6170-1070

Oct. 26, 2021

Yes

The image data related to the endpoints is submitted to the radiographic image judgment committee and evaluated by a third party.

none