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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comaneci Embolization Assist Device | Device | assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm. |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural Events | Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status. | 24 Hours post procedure |
| Adverse Events | All adverse events at discharge and up to 30 days post procedure. | 30 days post procedure |
| 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:
| 30 days post procedure |
| Number of Participants With 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 |
| Number of Participants With 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient with known hypersensitivity to nickel-titanium
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Hanel Ricardo, Dr. | Baptist Neurological Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USA Health University Hospital | Mobile | Alabama | 36617 | United States | ||
| Carondelet St. Joseph's Hospital (Tenet) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41260918 | Derived | Davies JM, Taqi MA, Coon AL, Lin LM, Bohnstedt B, Mascitelli J, Levy EI, Siddiqui A, Birnbaum L, Rodriguez P, Noufal M, Taussky P, Kilburg C, Gooch MR, Puri AS, Diaz O, Fifi JT, Majidi S, Yoo AJ, Soomro J, Bhuva P, Taylor RA, Oni-Orisan AO, Chen M, Sauvageau E, Cordina SM, Sugg RM, Singh J, Goren O, Liebeskind DS, Hanel RA. Comaneci-assisted embolization of wide-necked aneurysms: results from the SUCCESS postmarket US study. J Neurointerv Surg. 2025 Nov 19:jnis-2025-024136. doi: 10.1136/jnis-2025-024136. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated With the Comaneci | Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Coil Embolization of Wide-necked Intracranial Aneurysms Treated With the Comaneci | Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Periprocedural Events | Rates of all adverse events occurring within 24 hours post-procedure and hospital discharge status. | Posted | Number | Events | 24 Hours post procedure |
|
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated With the Comaneci | Coil embolization of wide-necked intracranial aneurysms treated with the Comaneci |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Walid Haddad- Chief Clinical Officer | Rapid-Medical | +972 72 2503331 | walid@rapid-medical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2023 | Dec 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Number of Participants With 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 |
| Tucson |
| Arizona |
| 85711 |
| United States |
| Santa Barbara Cottage | Santa Barbara | California | 93105 | United States |
| Los Robles | Thousand Oaks | California | 91360 | United States |
| Baptist Health Research Institute | Jacksonville | Florida | 32207 | United States |
| St. Mary's Medical Ctr (Tenet) | West Palm Beach | Florida | 33407 | United States |
| University of Buffalo | Buffalo | New York | 14203 | United States |
| Texas Stroke Institute (Sarah Cannon TN) | Dallas | Texas | 75075 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Admitted with ruptured aneurysms | Count of Participants | Participants |
|
| Elective cases with unruptured aneurysms. | Count of Participants | Participants |
|
|
| Primary | Adverse Events | All adverse events at discharge and up to 30 days post procedure. | Posted | Number | Events | 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:
| Posted | Number | participants | 30 days post procedure |
|
|
|
| Primary | Number of Participants With 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). | Posted | Count of Participants | Participants | end of procedure |
|
|
|
| Primary | Number of Participants With 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. | Posted | Count of Participants | Participants | 6 Months Post procedure |
|
|
|
| Primary | Number of Participants With 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 | Posted | Count of Participants | Participants | 6 Months Post procedure |
|
|
|
| 4 |
| 90 |
| 37 |
| 90 |
| 22 |
| 90 |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Systematic Assessment |
|
| Cardiac disorders | Cardiac disorders | Systematic Assessment |
|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
|
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Product issues | Product Issues | Systematic Assessment |
|
| Psychiatric disorders | Psychiatric disorders | Systematic Assessment |
|
| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vascular disorders | Vascular disorders | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|
|
| 3 |
|
| 4 |
|
| 5 |
|
| 6 |
|