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

Intracranial Aneurysm Clinical Trial

Official title:

Success in Comaneci-assist Coils Embolization Surveillance Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04518670
• Other study ID #: CLN-Co-001
• Status: Active, not recruiting
• Start date: November 24, 2020
• Est. completion date: July 10, 2024

Study information

• Verified date: October 2023
• Source: Rapid Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 10, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

Device:
• Comaneci Embolization Assist Device
assist in the coil embolization of wide-necked intracranial aneurysms with a neck width = 10 mm.

Locations

Country	Name	City	State
United States	University of Buffalo	Buffalo	New York
United States	Texas Stroke Institute (Sarah Cannon TN)	Dallas	Texas
United States	Baptist Health Research Institute	Jacksonville	Florida
United States	USA Health University Hospital	Mobile	Alabama
United States	Santa Barbara Cottage	Santa Barbara	California
United States	Los Robles	Thousand Oaks	California
United States	Carondelet St. Joseph's Hospital (Tenet)	Tucson	Arizona
United States	St. Mary's Medical Ctr (Tenet)	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rapid Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periprocedural events	Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.	24 Hours post procedure
Primary	Adverse events	All adverse events at discharge and up to 30 days post procedure.	30 days post procedure
Primary	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.	30 days post procedure
Primary	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).	end of procedure
Primary	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.	6 Months Post procedure
Primary	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	6 Months Post procedure