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

Rapid Medical90 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Intracranial Aneurysm

Interventions

Comaneci Embolization Assist DeviceDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (8)

USA Health University Hospital

Mobile, Alabama, United States

Carondelet St. Joseph's Hospital (Tenet)

Tucson, Arizona, United States

Santa Barbara Cottage

Santa Barbara, California, United States

Los Robles

Thousand Oaks, California, United States

Outcomes

Primary Outcomes

Periprocedural Events

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

Time frame: 24 Hours post procedure

Adverse Events

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

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 6 Months Post procedure

Number of Participants With Good Clinical Outcome

Data from ClinicalTrials.gov

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