Clinical trial NCT04518670: Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
Official title: Success in Comaneci-assist Coils Embolization Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Rapid Medical
aneurysm
Comaneci
Neurovascular intervention
Brain
Lead sponsor: Rapid Medical
Sponsor class: INDUSTRY
First posted: 2020-08-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Periprocedural events
timeFrame: 24 Hours post procedure
measure: Adverse events
timeFrame: 30 days post procedure
measure: Functional status
timeFrame: 30 days post procedure
measure: Successful intracranial aneurysm occlusion
timeFrame: end of procedure
measure: Successful intracranial aneurysm (IA) occlusion
timeFrame: 6 Months Post procedure
measure: Good clinical outcome
timeFrame: 6 Months Post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Health University Hospital
state: Alabama
city: Tucson
country: United States
facility: Carondelet St. Joseph's Hospital (Tenet)
state: Arizona
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage
state: California
city: Thousand Oaks
country: United States
facility: Los Robles
state: California
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: St. Mary's Medical Ctr (Tenet)
state: Florida
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Dallas
country: United States
facility: Texas Stroke Institute (Sarah Cannon TN)
state: Texas
Study officials:
affiliation: Baptist Neurological Institute
name: Hanel Ricardo, Dr.
role: PRINCIPAL_INVESTIGATOR
References: