Active — Not RecruitingNot Applicable

Kaneka Endovascular Embolization and Protection

United States164 participantsStarted 2022-12-13

Plain-language summary

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

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Adequate Occlusion

Timeframe: 12 months

Trial details

NCT IDNCT05563051

SponsorKaneka Medical America LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Aneurysm Cerebral trials