Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)

January 15, 2026 updated by: Rapid Medical

Success in Comaneci-assist Coils Embolization Surveillance Study

The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. A wide-necked intracranial aneurysm (IA) defines the neck width as ≥ 4 mm or a dome-to-neck ratio < 2.

The objective of the Postmarket Surveillance Plan is to assess safety and performance as used in postmarket clinical practice in the U.S.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • USA Health University Hospital
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Carondelet St. Joseph's Hospital (Tenet)
    • California
      • Santa Barbara, California, United States, 93105
        • Santa Barbara Cottage
      • Thousand Oaks, California, United States, 91360
        • Los Robles
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Baptist Health Research Institute
      • West Palm Beach, Florida, United States, 33407
        • St. Mary's Medical Ctr (Tenet)
    • New York
      • Buffalo, New York, United States, 14203
        • University of Buffalo
    • Texas
      • Dallas, Texas, United States, 75075
        • Texas Stroke Institute (Sarah Cannon TN)

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The Postmarket Sureveillance Study will include male or female patients with wide-necked ruptured and/or unruptured intracranial aneurysms that may require adjunctive assistance with coil embolization during the surgical procedure.

Description

Inclusion Criteria:

  1. Patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils.
  2. Patient is considered for treatment with coil embolization assisted by the Comaneci Device for wide-necked intracranial aneurysms with neck width ≤ 10 mm. A wide-necked intracranial aneurysm is defined by the neck width as ≥ 4 mm or a dome-to-neck ratio < 2.
  3. A signed informed consent by the patient or legally authorized representative

Exclusion Criteria:

1. Patient with known hypersensitivity to nickel-titanium

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural Events
Time Frame: 24 Hours post procedure
Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.
24 Hours post procedure
Adverse Events
Time Frame: 30 days post procedure
All adverse events at discharge and up to 30 days post procedure.
30 days post procedure
Functional Status
Time Frame: 30 days post procedure

Functional status at discharge and 30 days assessed using the modified Rankin Scale (mRS).

using the modified Rankin Scale (mRS). This scale runs from 0-6, from no symptoms to death as follows:

  • 0 - No symptoms
  • 1 - No significant disability. Able to carry out all usual activities, despite some symptoms.
  • 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  • 3 - Moderate disability. Requires some help, but able to walk unassisted.
  • 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  • 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  • 6 - Dead.
30 days post procedure
Number of Participants With Successful Intracranial Aneurysm Occlusion
Time Frame: end of procedure
Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA).
end of procedure
Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion
Time Frame: 6 Months Post procedure
Successful intracranial aneurysm (IA) occlusion, that is a stable IA occlusion, measured by Raymond Roy classification I or II taken at 6 months (± 21d) post procedure without the need for re-treatment of the target IA, using DSA.
6 Months Post procedure
Number of Participants With Good Clinical Outcome
Time Frame: 6 Months Post procedure
Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis
6 Months Post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rapid Medical

Investigators

  • Principal Investigator: Hanel Ricardo, Dr., Baptist Neurological Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

November 24, 2020

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

July 7, 2024

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 16, 2020

First Posted (Actual)

August 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-Co-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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