Intracranial AneurysmNCT04518670
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
An observational study of Intracranial Aneurysm, run by Rapid Medical at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Comaneci Embolization Assist Device
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 8 sitesUnited States
- Study dates
- 24 Nov 2020to 7 Jul 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Postmarket Sureveillance Study will include male or female patients with wide-necked ruptured and/or unruptured intracranial aneurysms that may require adjunctive assistance with coil embolization during the surgical procedure.
Who may be able to join
- 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
Who cannot join
- 1. Patient with known hypersensitivity to nickel-titanium
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Buffalo
Buffalo, New York, 14203
Texas Stroke Institute (Sarah Cannon TN)
Dallas, Texas, 75075
Baptist Health Research Institute
Jacksonville, Florida, 32207
USA Health University Hospital
Mobile, Alabama, 36617
Santa Barbara Cottage
Santa Barbara, California, 93105
Los Robles
Thousand Oaks, California, 91360
Carondelet St. Joseph's Hospital (Tenet)
Tucson, Arizona, 85711
St. Mary's Medical Ctr (Tenet)
West Palm Beach, Florida, 33407
About this study
Official title: Success in Comaneci-assist Coils Embolization Surveillance Study
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
- Being tested
- Comaneci Embolization Assist Device
- Keywords
- Rapid Medical, aneurysm, Comaneci, Neurovascular intervention, Brain
- Medical subject headings
- Intracranial Aneurysm, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comaneci Embolization Assist DeviceDevice
assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Periprocedural Events
Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.
Measured: 24 Hours post procedure
Adverse Events
All adverse events at discharge and up to 30 days post procedure.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 Months Post procedure
Number of Participants With Good Clinical Outcome
Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis
Measured: 6 Months Post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start24 Nov 2020
- Primary completion1 May 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Rapid Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanel Ricardo, Dr., Principal investigator, Baptist Neurological Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518670
- Sponsor's protocol ID
- CLN-Co-001
- Status last verified
- Nov 2024
- First submitted
- 11 Aug 2020
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Davies JM, Taqi MA, Coon AL, Lin LM, Bohnstedt B, Mascitelli J, Levy EI, Siddiqui A, Birnbaum L, Rodriguez P, Noufal M, Taussky P, Kilburg C, Gooch MR, Puri AS, Diaz O, Fifi JT, Majidi S, Yoo AJ, Soomro J, Bhuva P, Taylor RA, Oni-Orisan AO, Chen M, Sauvageau E, Cordina SM, Sugg RM, Singh J, Goren O, Liebeskind DS, Hanel RA. Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study. J Neurointerv Surg. 2025 Nov 19:jnis-2025-024136. doi: 10.1136/jnis-2025-024136. Online ahead of print.
PubMed 41260918
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success in Comaneci-assist Coils Embolization Surveillance Study
- ClinicalTrials.gov ID
- NCT04518670
- Acronym / sponsor ID
- CLN-Co-001
- Conditions
- Intracranial Aneurysm
- Keywords
- Rapid Medical, aneurysm, Comaneci, Neurovascular intervention, Brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Rapid MedicalIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2020 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Postmarket Sureveillance Study will include male or female patients with wide-necked ruptured and/or unruptured intracranial aneurysms that may require adjunctive assistance with coil embolization during the surgical procedure.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Patient with known hypersensitivity to nickel-titanium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comaneci Embolization Assist Deviceassist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. | Device | – |
Primary outcome
Periprocedural Events
Time frame: 24 Hours post procedure
Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.
Adverse Events
Time frame: 30 days post procedure
All adverse events at discharge and up to 30 days post procedure.
Functional Status
Time frame: 30 days post procedure
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.
Number of Participants With Successful Intracranial Aneurysm Occlusion
Time frame: end of procedure
Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA).
Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion
Time frame: 6 Months Post procedure
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.
Number of Participants With Good Clinical Outcome
Time frame: 6 Months Post procedure
Good clinical outcome- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41260918Davies JM, Taqi MA, Coon AL, Lin LM, Bohnstedt B, Mascitelli J, Levy EI, Siddiqui A, Birnbaum L, Rodriguez P, Noufal M, Taussky P, Kilburg C, Gooch MR, Puri AS, Diaz O, Fifi JT, Majidi S, Yoo AJ, Soomro J, Bhuva P, Taylor RA, Oni-Orisan AO, Chen M, Sauvageau E, Cordina SM, Sugg RM, Singh J, Goren O, Liebeskind DS, Hanel RA. Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study. J Neurointerv Surg. 2025 Nov 19:jnis-2025-024136. doi: 10.1136/jnis-2025-024136. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Intracranial Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanel Ricardo, Dr. principal investigator
Baptist Neurological Institute
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Rapid Medical at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periprocedural Events (time frame: 24 Hours post procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.