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

Rapid Medical

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Comaneci Embolization Assist Device

Study type: Observational

Funder types: Industry

Identifiers

NCT04518670

CLN-Co-001

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design