Kaneka Endovascular Embolization and Protection

Description

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

Conditions

Aneurysm Cerebral

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Study Overview

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Study Details

Study overview

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

Kaneka Endovascular Embolization and Protection

Kaneka Endovascular Embolization and Protection

Condition
Aneurysm Cerebral
Intervention / Treatment

-

Contacts and Locations

Grand Blanc

McLaren Health Care, Grand Blanc, Michigan, United States, 48439

New York

Northwell Health Lenox Hill Hospital, New York, New York, United States, 10075

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Oklahoma City

SSM Health St. Anthony's Hospital, Oklahoma City, Oklahoma, United States, 73102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kaneka Medical America LLC,

Ajit Puri, MD, PRINCIPAL_INVESTIGATOR, University of Massachusetts, Worcester

Mohamed Hussain, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-10