RECRUITING

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

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 prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System. The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures.

Official Title

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Quick Facts

Study Start:2023-11-01
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06282939

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient age ≥ 18 years;
  2. 2. Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
  3. 3. OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
  4. 4. Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study
  5. 5. Subject willing to comply with the protocol follow-up requirements; and
  6. 6. Hunt \& Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.
  1. 1. Life expectancy less than 1 year.
  2. 2. Patient previously enrolled in the OPTIMA Registry.
  3. 3. Known multiple intracranial aneurysms, apart from the targeted aneurysm for the OPTIMA study, requiring treatment during the index procedure or within the study follow-up period.
  4. 4. Patient is unwilling or unable to comply with the protocol follow-up schedule and/or based on the Investigator's judgment the patient is not a good registry candidate.
  5. 5. Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion.
  6. 6. Pre-planned staged procedures on unruptured target aneurysms

Contacts and Locations

Study Contact

Allison Kiser
CONTACT
812-617-5328
allison.kiser@hcahealthcare.com
Gina Remington
CONTACT
352-745-0055
gina.remington@hcahealthcare.com

Principal Investigator

Albert Yoo
PRINCIPAL_INVESTIGATOR
HCA Research Institute

Study Locations (Sites)

Med City Plano
Plano, Texas, 75075
United States

Collaborators and Investigators

Sponsor: HCA Healthcare Research Institute

  • Albert Yoo, PRINCIPAL_INVESTIGATOR, HCA Research Institute

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 Date2023-11-01
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Intracranial Aneurysm