ACTIVE_NOT_RECRUITING

Kaneka Endovascular Embolization and Protection

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Conditions

Aneurysm Cerebralaneurysmcoili-ED COILembolizationneuro endovascular

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Kaneka Endovascular Embolization and Protection

Quick Facts

Study Start:2022-12-13
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05563051

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Target aneurysm of 4mm - 14mm in size
  2. * Ruptured or unruptured
  3. * Suitable for embolization with coils
  4. * May be treated with or without assist devices
  1. * Unstable neurological deficit in unruptured cases (condition worsening within last 90 days)
  2. * Pre-planned staged procedure of target aneurysm
  3. * mRS score 3 or more
  4. * Hunt Hess Score more than 3 for subjects with ruptured aneurysm
  5. * Evidence of active infection (e.g.,fever, temperature \>38 degrees C and/or WBC \>15,000)

Contacts and Locations

Principal Investigator

Ajit Puri, MD
PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Mohamed Hussain, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

McLaren Health Care
Grand Blanc, Michigan, 48439
United States
Northwell Health Lenox Hill Hospital
New York, New York, 10075
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
SSM Health St. Anthony's Hospital
Oklahoma City, Oklahoma, 73102
United States

Collaborators and Investigators

Sponsor: Kaneka Medical America LLC

  • Ajit Puri, MD, PRINCIPAL_INVESTIGATOR, University of Massachusetts, Worcester
  • Mohamed Hussain, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • aneurysm
  • coil
  • i-ED COIL
  • embolization
  • neuro endovascular

Additional Relevant MeSH Terms

  • Aneurysm Cerebral