Exploratory research of neointimal formation after stent and optimal duration of dual antiplatelet therapy

JRCT ID: jRCTs032240032

Registered date:16/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intracranial aneurysm
• Date of first enrollment: 16/04/2024
• Target sample size: 6
• Study type: Interventional
• Intervention(s): OCT is performed to evaluate neointima over the stent struts at 1, 3 and 6 months after placement of flow diverter.

Outcome(s)

Primary Outcome

Period that All stent struts are covered completely.
Safety: all adverse events, medical noncomformity

Secondary Outcome

Position that initiatial neointima is covered on stent struts.
Eccentricity of neointima covered on stent struts.
Period of discontinuation of dual antiplatelet therapy
Adhesion ratio between stent strut and vessel wall

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Patients that placement of flow diverter is scheduled for intracranial aneurysm.
2) Patients that infromed consent was obtained.
3) between 18 and 80 years old.

Exclude criteria

1) Patient that antiplatelet therapy and anticoagulant therapy is not available.
2) Patient with allergy for drugs used under procedure.
3) Patient that cerebral angiography is difficult to be performed.
4) Patient that investigator judged inappropriate in this research.

Related Information

• Primary Sponsor: Matsuda Yoshikazu