Trial Outcomes & Findings for Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS) (NCT NCT04518670)

NCT ID: NCT04518670

Last Updated: 2026-01-21

Results Overview

Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.

• Recruitment status: COMPLETED
• Target enrollment: 90 participants
• Primary outcome timeframe: 24 Hours post procedure
• Results posted on: 2026-01-21

Participant Flow

Participant milestones

Measure	Treated With the Comaneci Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci
Overall Study STARTED	90
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Coil Embolization of Wide-necked Intracranial Aneurysms Treated With the Comaneci n=90 Participants Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci
Age, Continuous	63 years n=37 Participants
Sex: Female, Male Female	57 Participants n=37 Participants
Sex: Female, Male Male	33 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=37 Participants
Race (NIH/OMB) Asian	3 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	15 Participants n=37 Participants
Race (NIH/OMB) White	66 Participants n=37 Participants
Race (NIH/OMB) More than one race	5 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants
Region of Enrollment United States	90 participants n=37 Participants
Admitted with ruptured aneurysms	32 Participants n=37 Participants
Elective cases with unruptured aneurysms.	58 Participants n=37 Participants

PRIMARY outcome

Timeframe: 24 Hours post procedure

Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.

Outcome measures

Measure	Coil Embolization With Comaneci n=90 Participants Coil Embolization with Comaneci
Periprocedural Events	79 Events

PRIMARY outcome

Timeframe: 30 days post procedure

All adverse events at discharge and up to 30 days post procedure.

Outcome measures

Measure	Coil Embolization With Comaneci n=90 Participants Coil Embolization with Comaneci
Adverse Events	150 Events

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coil Embolization With Comaneci n=88 Participants Coil Embolization with Comaneci
Functional Status 0	41 participants
Functional Status 1	21 participants
Functional Status 2	9 participants
Functional Status 3	5 participants
Functional Status 4	4 participants
Functional Status 5	6 participants
Functional Status 6	2 participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Coil Embolization With Comaneci n=90 Participants Coil Embolization with Comaneci
Number of Participants With Successful Intracranial Aneurysm Occlusion	77 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Coil Embolization With Comaneci n=75 Participants Coil Embolization with Comaneci
Number of Participants With Successful Intracranial Aneurysm (IA) Occlusion	70 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Coil Embolization With Comaneci n=90 Participants Coil Embolization with Comaneci
Number of Participants With Good Clinical Outcome	57 Participants

Adverse Events

Treated With the Comaneci

Serious events: 37 serious events

Other events: 22 other events

Deaths: 4 deaths

Serious adverse events

Measure	Treated With the Comaneci n=90 participants at risk Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci
Nervous system disorders Nervous system disorders	23.3% 21/90 • Number of events 39 • 30 days
Blood and lymphatic system disorders Blood and lymphatic system disorders	2.2% 2/90 • Number of events 2 • 30 days
Cardiac disorders Cardiac disorders	1.1% 1/90 • Number of events 2 • 30 days
Gastrointestinal disorders Gastrointestinal disorders	3.3% 3/90 • Number of events 3 • 30 days
General disorders General disorders and administration site conditions	5.6% 5/90 • Number of events 5 • 30 days
Infections and infestations Infections and infestations	4.4% 4/90 • Number of events 5 • 30 days
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	2.2% 2/90 • Number of events 2 • 30 days
Investigations Investigations	1.1% 1/90 • Number of events 1 • 30 days
Product Issues Product issues	4.4% 4/90 • Number of events 4 • 30 days
Psychiatric disorders Psychiatric disorders	2.2% 2/90 • Number of events 2 • 30 days
Reproductive system and breast disorders Reproductive system and breast disorders	1.1% 1/90 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	5.6% 5/90 • Number of events 8 • 30 days
Vascular disorders Vascular disorders	15.6% 14/90 • Number of events 16 • 30 days

Other adverse events

Measure	Treated With the Comaneci n=90 participants at risk Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci
Nervous system disorders Nervous system disorders	24.4% 22/90 • 30 days

Additional Information

Dr. Walid Haddad- Chief Clinical Officer

Rapid-Medical

Phone: +972 72 2503331

Email: walid@rapid-medical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place