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

NCT04518670 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2026-01-21

Study results available
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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.

Conditions

  • Intracranial Aneurysm

Interventions

DEVICE

Comaneci Embolization Assist Device

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

Sponsors & Collaborators

  • Rapid Medical

    lead INDUSTRY

Principal Investigators

  • Hanel Ricardo, Dr. · Baptist Neurological Institute

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2024-05-01
Completion
2024-07-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04518670 on ClinicalTrials.gov