Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry

NCT06282939 | Recruiting DMC FDA Device

• 1 other identifier: 20234314
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (5)

• Measure Adequate Occlusion Using modified Raymond-Roy Occlusion Class (MRRC) I and II score

  Rated by a designated core lab without retreatment as confirmed by core lab adjudication.

  1 year follow up +/- 90 days

• Assess coiling alone or in combination with adjunctive devices for approximately 400 patients

  Subgroup using adjunctive devices include including balloon remodeling and stenting

  1 year follow up +/- 90 days

• Evaluate Coiling with flow diversion for approximately 200 subjects

  Subgroup utilizing flow diverter for approximately 200 subjects

  1 year follow up +/- 90 days

• Subgroup analyses will be performed examining:

  Aneurysms treated predominantly (≥50%) with Balt manufactured coils will also be analyzed for the number of coils utilized per aneurysm and procedure duration

  1 year follow up +/- 90 days

• Analyze outcomes of small aneurysms defined as smaller than 5mm

  Outcomes of small aneurysms defined as smaller than 5mm

  1 year follow up +/- 90 days

Secondary Outcomes (9)

• Adequate occlusion

  Immediate Post Procedure

• Packing density

  Day 1

• Complete occlusion

  1 Year post- procedure

• Complete occlusion

  Immediate post procedure

• Recanalization rate

  1 year post procedure

Other Outcomes (2)

• Primary Safety Endpoint

  7 days post-procedure or discharge

• Secondary Safety Endpoint

  12 months post enrollment

Interventions

OPTIMA and OPTIMAX Coils manufactured by Balt USA DEVICE

\*Percentage from protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

600 subjects with intracranial saccular aneurysms (maximum dimension ≤ 24 mm), ruptured or unruptured, treated with the OptimaTM Coil System.

You may qualify if:

• Patients enrolled in this registry must be treated in accordance with the FDA-cleared indication for the Optima Coil System.
• In addition:
• Patient age ≥ 18 years;
• Candidate aneurysm is a previously untreated, saccular intracranial aneurysm measuring ≤ 24 mm in maximal diameter and suitable for embolization with coils;
• OptimaTM coil system accounts for at least 75% of the total number of implanted coils;
• Patient/ LARreceived the IRB-approved Consent Information Sheet to augment clinical procedure consent, and provided verbal consent to participate in the study
• Subject willing to comply with the protocol follow-up requirements; and
• Hunt \& Hess classification of equal to or less than 4 for ruptured aneurysms, if applicable.

You may not qualify if:

• Life expectancy less than 1 year.
• Patient previously enrolled in the OPTIMA Registry.
• 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.
• 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.
• Participation in another confirmed interventional clinical study that could confound the evaluation of this registry, per PI discretion.
• Pre-planned staged procedures on unruptured target aneurysms

Sponsors & Collaborators

• HCA Healthcare Research Institute: lead
• Balt USA: collaborator

Study Sites (1)

Med City Plano

Plano, Texas, 75075, United States

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Albert Yoo

  HCA Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Kiser

CONTACT

812-617-5328; allison.kiser@hcahealthcare.com

Gina Remington

CONTACT

352-745-0055; gina.remington@hcahealthcare.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: February 28, 2024
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)