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

NCT04518670 | Completed Results FDA Device

• 1 other identifier: CLN-Co-001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Intracranial Aneurysm

Keywords

Rapid Medical; aneurysm; Comaneci; Neurovascular intervention; Brain

Outcome Measures

Primary Outcomes (6)

• Periprocedural Events

  Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.

  24 Hours post procedure

• Adverse Events

  All adverse events at discharge and up to 30 days post procedure.

  30 days post procedure

• Functional Status

  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

  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

  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

  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

Interventions

Comaneci Embolization Assist Device DEVICE

assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils.
• 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.
• A signed informed consent by the patient or legally authorized representative

You may not qualify if:

• \. Patient with known hypersensitivity to nickel-titanium

Sponsors & Collaborators

• Rapid Medical: lead

Study Sites (8)

USA Health University Hospital

Mobile, Alabama, 36617, United States

Location

Carondelet St. Joseph's Hospital (Tenet)

Tucson, Arizona, 85711, United States

Location

Santa Barbara Cottage

Santa Barbara, California, 93105, United States

Location

Los Robles

Thousand Oaks, California, 91360, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

St. Mary's Medical Ctr (Tenet)

West Palm Beach, Florida, 33407, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Texas Stroke Institute (Sarah Cannon TN)

Dallas, Texas, 75075, United States

Location

Related Publications (1)

• Davies JM, Taqi MA, Coon AL, Lin LM, Bohnstedt B, Mascitelli J, Levy EI, Siddiqui A, Birnbaum L, Rodriguez P, Noufal M, Taussky P, Kilburg C, Gooch MR, Puri AS, Diaz O, Fifi JT, Majidi S, Yoo AJ, Soomro J, Bhuva P, Taylor RA, Oni-Orisan AO, Chen M, Sauvageau E, Cordina SM, Sugg RM, Singh J, Goren O, Liebeskind DS, Hanel RA. Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study. J Neurointerv Surg. 2025 Nov 19:jnis-2025-024136. doi: 10.1136/jnis-2025-024136. Online ahead of print.

  PMID: 41260918 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Walid Haddad- Chief Clinical Officer
• Organization: Rapid-Medical

walid@rapid-medical.com

+972 72 2503331

Study Officials

• Hanel Ricardo, Dr.

  Baptist Neurological Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 19, 2020
• Study Start: November 24, 2020
• Primary Completion: May 1, 2024
• Study Completion: July 7, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)