Kaneka Endovascular Embolization and Protection (KEEP)

Kaneka

Status: Enrolling

Conditions: Aneurysm Cerebral

Treatments: Device: i-ED COIL

Study type: Interventional

Funder types: Industry

Identifiers

NCT05563051

KMA-IVRNV-001

Details and patient eligibility

About

Prospective, multi-center, non-randomized registry / study, up to 164 patients enrolled and followed at 180 days +/- 45 days and again at 365 days +/- 90 days post procedure

Full description

Assess and describe real world clinical data on i-ED coils Characterize the acute and long-term performance of iED coils when used for treating for an intracranial aneurysm May be used alone or in combination with other adjunctive device(s)

Study Duration

Anticipated timeline for study:

Patient enrollment in 18 - 24 months Completion of follow-up 12 months after last patient enrolled

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Target aneurysm of 4mm - 14mm in size
• Ruptured or unruptured
• Suitable for embolization with coils
• May be treated with or without assist devices

Exclusion criteria

• Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
• Pre-planned staged procedure of target aneurysm
• mRS score 3 or more
• Hunt Hess Score more than 3 for subjects with ruptured aneurysm
• Evidence of active infection (e.g.,fever, temperature >38 degrees C and/or WBC >15,000)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

Interventional treatment

Other group

Description:

Open label

Treatment:

Device: i-ED COIL