Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT04518670
- Lead Sponsor
- Rapid Medical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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
- Patient with known hypersensitivity to nickel-titanium
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.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.
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
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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
USA Health University Hospital
🇺🇸Mobile, Alabama, United States
Santa Barbara Cottage
🇺🇸Santa Barbara, California, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
Carondelet St. Joseph's Hospital (Tenet)
🇺🇸Tucson, Arizona, United States
St. Mary's Medical Ctr (Tenet)
🇺🇸West Palm Beach, Florida, United States
Los Robles
🇺🇸Thousand Oaks, California, United States
Texas Stroke Institute (Sarah Cannon TN)
🇺🇸Dallas, Texas, United States