Clinical Study to Assess Deliverability, Visibility, Safety, and Performance of the IntraCranial Stent System for Endovascular Treatment of Unruptured Wide-Necked Aneurysms

JRCT ID: jRCTs052230038

Registered date:13/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebral aneurysm
• Date of first enrollment: 30/10/2023
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Treatment with unapproved equipment

Outcome(s)

Primary Outcome

1) Successful stent placement, coil mass maintained in cerebral aneurysm at 180 days post DSA, stent open.
2) All-cause mortality within 30 days after surgery and major stroke in the area of stenting attributable to device or therapy

Secondary Outcome

1) Re-treatment of cerebral aneurysm 180 days after surgery
2) Obstruction or stenosis at the stenting site at 180 days postoperatively
3) Occlusion of cerebral aneurysm after treatment and 180 days postoperatively
4) Hemorrhagic stroke or severe hemorrhage in the first 180 days after surgery
5) Ischemic stroke in the therapeutic vascular territory during the first 180 days after surgery
6) mRS 180 days after surgery
7) Adverse events 7 days postoperatively or until discharge
8) Equipment failure

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1) Patients with wide-necked unruptured cerebral aneurysms
2) Anatomical indications for stent-assisted coil embolization
3) Age between 18 and 85 at the time of consent
4) mRS score of 0-2 at the time of consent
5) Persons who have obtained written consent from the individual

Exclude criteria

1)Persons with hypersensitivity to nickel and titanium
2)Those who are unable to take antiplatelet medications
3)Previous surgical or endovascular treatment of target aneurysm
4)Those who have another cerebral aneurysm requiring treatment within 180 days after surgery
5)Those whose estimated life expectancy at the time of consent is less than 180 days, or for whom 180 days of follow-up is deemed difficult.
6)Is pregnant or wishes to become pregnant during the study period
7)Participants in other clinical trials or intervention studies
8)Persons whom the principal investigator or subinvestigator determines are not appropriate to participate in this study

Related Information

• Primary Sponsor: Sakai Nobuyuki
• Secondary Sponsor: Imperative Care