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 range18 Years – 85 Years

SexALL

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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

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