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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS190001 / PSS001 |
| Date Original Plan Accepted |
08/06/2020
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| Date Current Plan Accepted |
03/07/2023
|
| Study Name |
Success in Comaneci-Assist Coils Embolization Surv
|
| Device Name |
Comaneci embolization assist device
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| Root Document Number |
DEN170064
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a multicenter, single arm, open, prospective, postmarket safety surveillance in up to 30 US centers. The objective of the Postmarket Surveillance Plan is to assess safety and performance of Comaneci Embolization Assist Device as used in postmarket clinical practice in the U.S.
Surveillance is to continue until complete data on the deployment of 90 devices with complete 30-day patient status are obtained. No more than 13 subjects should be enrolled at each clinical center.
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| 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.
Inclusion Criteria:
In order to assure that the probable benefits outweigh the probable risks for the Comaneci Embolization Assist Device, as indicated in the IFU, the subjects must meet all of the following 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 less than or equal to 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:
Patient should be treated by the Comaneci device in accordance with the approved device label. (i.e. doesn’t meet the contraindication criteria, as described in the IFU):
1. Patient with known hypersensitivity to nickel-titanium.
|
| Sample Size |
90 evaluable subjects
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| Key Study Endpoints |
Safety
• Periprocedural events*: Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status.
• All adverse events at discharge and up to 30 days post procedure.
• Functional status at discharge and 30 days assessed using the modified Rankin Scale (mRS).
Secondary safety endpoint: evaluation of the extent of any relationship between adverse event rate to operator experience.
(*) Including vessel perforation or dissection, intracranial aneurysm rupture, stroke, hemorrhage, death, inability to deploy or remove the device, and coil entanglement
Effectiveness Outcome
• Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure, using digital subtraction angiography (DSA).
• 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- mRS shift @ 6 months (change @ 6 months from pre procedure) and tetrachotomized (0,1, 2, 3-6) mRS analysis.
|
| Follow-up Visits and Length of Follow-up |
180 DAYS
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
90
|
| Actual Number of Sites Enrolled |
17
|
| Patient Followup Rate |
A total of 90 subjects have been enrolled as of Oct 18, 2023 and the last follow up visit was conducted on 01-May-2024. Five (5) subjects terminated early (including 4 subjects died before the 180 days follow up), three (3) subjects lost to follow up, and three (3) subjects withdrew. Follow-up rate at 30-day is 96.6% (87/90) and at 180-day is 87.7%(79/90). No concern.
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| Final Safety Findings |
Safety data is summarized in Table 20 (by rupture status). See assessment below for more detail.
254 AEs were reported in 59/90 (65.5%) subjects. One hundred sixty-four (164) were non serious adverse events. Ninety (90) were SAEs that occurred in 37/90 (41.41%) of subjects. Of the total AEs 51/254 events in 29/90 (32.2%) subjects were procedure/device related adverse events. 7 SADE events (2 events were definitely related to device) occurred in 5 subjects, one subject with ruptured aneurysm and 4 with unruptured aneurysms. All SADEs occurred within 48 hours post procedure.
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| Final Effectiveness Findings |
Effectiveness: Successful intracranial aneurysm occlusion (measured by Raymond Roy classification I or II) at the end of procedure was 77/90 (85.6%),
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| Study Strengths and Weaknesses |
Strength: prospective, multi-center study with good follow-up rate
Weakness: Single arm, observational study without hypothesis testing.
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| Recommendations for Labeling Changes |
No
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