Intracranial Aneurysm
Conditions
Keywords
Rapid Medical, aneurysm, Comaneci, Neurovascular intervention, Brain
Brief 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.
Interventions
DEVICEComaneci Embolization Assist Device
assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
Sponsors
Rapid Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has a documented intracranial ruptured or unruptured aneurysm, suitable for embolization by coils. 2. 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. 3. A signed informed consent by the patient or legally authorized representative
Exclusion criteria
1\. Patient with known hypersensitivity to nickel-titanium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural Events | 24 Hours post procedure | Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status. |
| Adverse Events | 30 days post procedure | All adverse events at discharge and up to 30 days post procedure. |
| Functional Status | 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 | 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 | 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 | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHanel Ricardo, Dr.
Baptist Neurological Institute
Baseline characteristics
| Characteristic | — |
|---|---|
| Admitted with ruptured aneurysms | 32 Participants |
| Age, Continuous | 63 years |
| Elective cases with unruptured aneurysms. | 58 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 66 Participants |
| Region of Enrollment United States | 90 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 90 |
| other Total, other adverse events | 22 / 90 |
| serious Total, serious adverse events | 37 / 90 |
Outcome results
None listed