ACTIVE_NOT_RECRUITING

Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

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Conditions

Intracranial AneurysmsWide Neck Intracranial Aneurysms

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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

This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.

Official Title

Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms

Quick Facts

Study Start:2023-06-02
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05636124

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. * Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team
  2. * Wide neck side wall or bifurcation intracranial aneurysms (neck \> or = to 4 mm or dome-to-neck ratio \< 2) within the anterior or posterior circulation
  3. * The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling)
  4. * Patients are 18-80 years of age (inclusive)
  5. * Patient must be Hunt and Hess grade 0 to 3
  6. * Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
  7. * Aneurysm 6-14 mm in diameter
  8. * Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment
  9. * The patient has not been previously enrolled in this trial or another related ongoing trial
  10. * The aneurysm has not been previously treated by coiling or clipping
  1. * Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses).
  2. * Target aneurysm has had previous coil treatment or has been surgically clipped
  3. * Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
  4. * Inability to obtain informed consent
  5. * Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years

Contacts and Locations

Principal Investigator

Reade De Leacy
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Sutter Health
Danville, California, 94526
United States
Baptist Health Jacksonville
Jacksonville, Florida, 32207
United States
University of South Florida
Tampa, Florida, 33606
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Prisma Health
Greenville, South Carolina, 29605
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Reade De Leacy, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Date2023-06-02
Study Completion Date2027-07

Study Record Updates

Study Start Date2023-06-02
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Intracranial Aneurysms
  • Wide Neck Intracranial Aneurysms