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

Completed

Conditions studied: Intracranial Aneurysm

In brief

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.

Key facts

Study ID

NCT04518670

Run by

Rapid Medical

People needed

90

Starts

2020-11-24

Expected to finish

2024-07-07

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Baptist Health Research Institute — Jacksonville, Florida, United States
• St. Mary's Medical Ctr (Tenet) — West Palm Beach, Florida, United States
• University of Buffalo — Buffalo, New York, United States
• Texas Stroke Institute (Sarah Cannon TN) — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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