CompletedNot Applicable

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

United States90 participantsStarted 2020-11-24

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Periprocedural Events

Timeframe: 24 Hours post procedure

Adverse Events

Timeframe: 30 days post procedure

Functional Status

Timeframe: 30 days post procedure

Number of Participants With Successful Intracranial Aneurysm Occlusion

Timeframe: end of procedure

Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion

Timeframe: 6 Months Post procedure

Number of Participants With Good Clinical Outcome

Timeframe: 6 Months Post procedure

Trial details

NCT IDNCT04518670

SponsorRapid Medical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-05-01

Results submitted2025-12-23

View on ClinicalTrials.gov More Intracranial Aneurysm trials

Plain-language summary

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

What they're measuring

Periprocedural Events

Timeframe: 24 Hours post procedure

Adverse Events

Timeframe: 30 days post procedure

Functional Status

Timeframe: 30 days post procedure

Number of Participants With Successful Intracranial Aneurysm Occlusion

Timeframe: end of procedure

Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion

Timeframe: 6 Months Post procedure

Number of Participants With Good Clinical Outcome

Timeframe: 6 Months Post procedure