Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

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.

Conditions

Intracranial Aneurysm

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Study Overview

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Study Details

Study overview

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.

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

Condition
Intracranial Aneurysm
Intervention / Treatment

-

Contacts and Locations

Plano

Med City Plano, Plano, Texas, United States, 75075

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

  • 1. Patient age ≥ 18 years;
  • 2. Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
  • 3. OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
  • 4. Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study
  • 5. Subject willing to comply with the protocol follow-up requirements; and
  • 6. Hunt \& Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.
  • 1. Life expectancy less than 1 year.
  • 2. Patient previously enrolled in the OPTIMA Registry.
  • 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. 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. Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion.
  • 6. Pre-planned staged procedures on unruptured target aneurysms

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

HCA Healthcare Research Institute,

Albert Yoo, PRINCIPAL_INVESTIGATOR, HCA Research Institute

Study Record Dates

2027-12-01