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A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coils | Other | MICRUSFRAME and GALAXY coils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MICRUSFRAME and GALAXY coils | Device | MICRUSFRAME and GALAXY Coils |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Adequate Occlusion (Modified Raymond-Roy I or II Classification) as Assessed by the Independent Core Lab Report of the Target Aneurysm at 1 Year Without Retreatment | Number of participants who achieved adequate occlusion as assessed by the independent core lab report of the target aneurysm at 1 year without retreatment was reported. Adequate occlusion was defined as the achievement of a Modified Raymond-Roy classification of the aneurysm at 1 year without retreatment. Modified Raymond-Roy Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. | At 1 year Post Procedure on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Packing Density Percentage (%) as Assessed by Independent Core Lab | Packing density was defined as the ratio of the volume of coils to the volume of the coiled part of the aneurysm achieved during the procedure. Packing density is expressed as percentage. | During procedure (Day 1) |
| Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reade De Leacy | Mount Sinai Hospital, New York | Principal Investigator |
| Osama Zaidat | Mercy Health St. Vincent Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States | ||
| Mercy San Juan Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | MICRUSFRAME and GALAXY Coils | Participants with intracranial saccular aneurysm, ruptured or unruptured, were treated with MICRUSFRAME and GALAXY coils. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2021 | Jun 12, 2026 |
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Number of participants with complete occlusion at 1 year was reported as assessed by the independent core lab was reported. Complete occlusion was defined as achieving Modified Raymond-Roy I classification at 1 year, as assessed by the independent core lab. Modified Raymond-Roy I or II Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. |
| At 1 year Post Procedure on Day 1 |
| Recanalization Rate at 1 Year as Assessed by Independent Core Lab | Recanalization rate is defined as number of participants with recanalization. Recanalization was defined as a worsening in aneurysm occlusion grading using the Modified Raymond-Roy Classification (MRRC) scale. MRRC scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. | At 1 year Post Procedure on Day 1 |
| Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms | Number of participants with mRS 0-2 with unruptured aneurysm was reported. The Modified Rankin Scale (mRS) is a 7 point measure of functional outcome ranging from 0 to 6, where higher scores indicate greater disability. A score of 0 reflects no symptoms, 1 denotes no significant disability despite minor symptoms, 2 indicates slight disability with independence in personal affairs, 3 corresponds to moderate disability requiring some help but able to walk unassisted, 4 represents moderately severe disability with dependence for bodily needs and inability to walk alone, 5 signifies severe disability requiring constant care, and 6 indicates death. Increasing scores indicate worsening outcomes. | From baseline (Day 1 of procedure) to 1 year post procedure on Day 1 |
| Number of Participants With Retreatment (Surgical or Endovascular) | Number of participants with any retreatment (surgical or endovascular) was reported. Retreatment is defined as any type of additional treatment (surgical or endovascular) of the target aneurysm after the index procedure. | From baseline (Day 1 of procedure) to 1 year post procedure on Day 1 |
| Number of Participants With Device Related Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. A serious adverse event (SAE) is defined as an adverse event that led to death, led to serious deterioration in the health of the participant, users, other persons as defined by one or more of the following: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function including chronic diseases, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function led to fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental impairment. | From Day of procedure (Day 1) up to 1 year |
| Carmichael |
| California |
| 95608 |
| United States |
| University of California Irvine | Orange | California | 92868 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Baptist Medical Center | Jacksonville | Florida | 32207 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Memorial Health University | Savannah | Georgia | 31405 | United States |
| Rush University | Chicago | Illinois | 60612 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| Javon Bea Hospital | Rockford | Illinois | 61103 | United States |
| Norton Healthcare | Louisville | Kentucky | 40241 | United States |
| Maine Medical Center | Scarborough | Maine | 04074 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| St. Louis University | St Louis | Missouri | 63110 | United States |
| University of Buffalo | Buffalo | New York | 14075 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Mercy Health St. Vincent Medical Center | Toledo | Ohio | 43604 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Greenville Health System | Greenville | South Carolina | 61103 | United States |
| Tennessee Interventional and Imaging Associates | Chattanooga | Tennessee | 37403 | United States |
| University of Tennessee | Knoxville | Tennessee | 37920 | United States |
| Texas Stroke Institute | Plano | Texas | 75075 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Algemeen Ziekenhuis Groeninge | Kortrijk | Belgium |
| Centre Hospitalier Universitaire d'Amiens Picardie | Amiens | France |
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | France |
| Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille | Lille | France |
| Praticien Hospitalier Université de Lorraine | Nancy | France |
| Centre Hospitalier Regional Universitaire de Tours | Tours | France |
| Universitatsklinikum Schleswig Holstein | Lübeck | Germany |
| Galilee Hospital Naharyia | Nahariya | Israel |
| Ospedale Niguarda Ca' Granda | Milan | Italy |
| Policlinico Tor Vergata | Roma | Italy |
| Ospedale Cannizzaro | Sicily | Italy |
| Aichi Medical University Hospital | Aichi | Japan |
| Okayama University Hospital | Okayama | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | Japan |
| Tominaga Hospital | Osaka | Japan |
| Kohnan Hospital | Sendai | Japan |
| Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital | Yokohama | Japan |
| Centro Hospitalar de Vila Nova de Gaia | Porto | Portugal |
| Hospital Universitari i Politecnic La Fe | Valencia | Spain |
| Hopitaux Universitaires de Geneve | Geneva | Switzerland |
| University Hospital Zurich | Zurich | Switzerland |
| Safety Analysis Set | Safety analysis set consisted of all enrolled participants in whom coil treatment was attempted as defined by advancement of a coil outside of the distal end of the microcatheter inside the participant. |
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| Per-Protocol Analysis Set | Per protocol (PP) analysis set consisted of participants in the safety analysis set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year digital subtraction angiography/magnetic resonance angiography (DSA/MRA). |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set consisted of all enrolled participants in whom coil treatment was attempted as defined by advancement of a coil outside of the distal end of the microcatheter inside the participant.
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| ID | Title | Description |
|---|---|---|
| BG000 | MICRUSFRAME and GALAXY Coils | Participants with intracranial saccular aneurysm, ruptured or unruptured, were treated with MICRUSFRAME and GALAXY coils. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Number of Participants Who Achieved Adequate Occlusion (Modified Raymond-Roy I or II Classification) as Assessed by the Independent Core Lab Report of the Target Aneurysm at 1 Year Without Retreatment | Number of participants who achieved adequate occlusion as assessed by the independent core lab report of the target aneurysm at 1 year without retreatment was reported. Adequate occlusion was defined as the achievement of a Modified Raymond-Roy classification of the aneurysm at 1 year without retreatment. Modified Raymond-Roy Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. | Per protocol (PP) analysis set consisted of participants in the safety analysis set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year Digital Subtraction Angiography (DSA) /Magnetic Resonance Angiography (MRA). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At 1 year Post Procedure on Day 1 |
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| Secondary | Packing Density Percentage (%) as Assessed by Independent Core Lab | Packing density was defined as the ratio of the volume of coils to the volume of the coiled part of the aneurysm achieved during the procedure. Packing density is expressed as percentage. | Per protocol (PP) analysis set consisted of participants in the safety analysis set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year Digital Subtraction Angiography (DSA) /Magnetic Resonance Angiography (MRA). | Posted | Mean | Standard Deviation | packing density percentage | During procedure (Day 1) |
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| Secondary | Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification) | Number of participants with complete occlusion at 1 year was reported as assessed by the independent core lab was reported. Complete occlusion was defined as achieving Modified Raymond-Roy I classification at 1 year, as assessed by the independent core lab. Modified Raymond-Roy I or II Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. | Per protocol (PP) analysis set consisted of participants in the safety analysis set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year Digital Subtraction Angiography (DSA) /Magnetic Resonance Angiography (MRA). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At 1 year Post Procedure on Day 1 |
| ||||||||||||||||||||||||||||
| Secondary | Recanalization Rate at 1 Year as Assessed by Independent Core Lab | Recanalization rate is defined as number of participants with recanalization. Recanalization was defined as a worsening in aneurysm occlusion grading using the Modified Raymond-Roy Classification (MRRC) scale. MRRC scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall. | Per protocol (PP) analysis set consisted of participants in the safety analysis set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year Digital Subtraction Angiography (DSA) /Magnetic Resonance Angiography (MRA). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At 1 year Post Procedure on Day 1 |
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| Secondary | Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms | Number of participants with mRS 0-2 with unruptured aneurysm was reported. The Modified Rankin Scale (mRS) is a 7 point measure of functional outcome ranging from 0 to 6, where higher scores indicate greater disability. A score of 0 reflects no symptoms, 1 denotes no significant disability despite minor symptoms, 2 indicates slight disability with independence in personal affairs, 3 corresponds to moderate disability requiring some help but able to walk unassisted, 4 represents moderately severe disability with dependence for bodily needs and inability to walk alone, 5 signifies severe disability requiring constant care, and 6 indicates death. Increasing scores indicate worsening outcomes. | Per protocol (PP) analysis set consisted of participants in the safety analysis set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year Digital Subtraction Angiography (DSA) /Magnetic Resonance Angiography (MRA). Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | From baseline (Day 1 of procedure) to 1 year post procedure on Day 1 |
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| Secondary | Number of Participants With Retreatment (Surgical or Endovascular) | Number of participants with any retreatment (surgical or endovascular) was reported. Retreatment is defined as any type of additional treatment (surgical or endovascular) of the target aneurysm after the index procedure. | Per protocol (PP) analysis set consisted of participants in the Safety Analysis Set who (1) met the eligibility criteria, (2) had been treated with at least 75% GALAXY/MICRUSFRAME coils by length, and (3) completed a 1-year Digital Subtraction Angiography (DSA) /Magnetic Resonance Angiography (MRA). | Posted | Count of Participants | Participants | From baseline (Day 1 of procedure) to 1 year post procedure on Day 1 |
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| Secondary | Number of Participants With Device Related Serious Adverse Events (SAEs) | An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. A serious adverse event (SAE) is defined as an adverse event that led to death, led to serious deterioration in the health of the participant, users, other persons as defined by one or more of the following: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function including chronic diseases, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function led to fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental impairment. | Safety analysis set consisted of all enrolled participants in whom coil treatment was attempted as defined by advancement of a coil outside of the distal end of the microcatheter inside the participant. | Posted | Count of Participants | Participants | From Day of procedure (Day 1) up to 1 year |
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From Day of procedure (Day 1) up to 1 year post procedure on Day 1
All-cause mortality: All enrolled participants; Serious and other AEs: Safety analysis set was used to report the serious and other AEs. Since this a post market registry, only serious adverse events with causal, probable or possible relationship to study device, intra-procedural aneurysm ruptures, and symptomatic thromboembolic events were considered reportable per the protocol.
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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 | MICRUSFRAME and GALAXY Coils | Participants with intracranial saccular aneurysm, ruptured or unruptured, were treated with MICRUSFRAME and GALAXY coils. | 17 | 723 | 20 | 703 | 5 | 703 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral artery thrombosis | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
| |
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
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| Carotid artery thrombosis | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
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| Aneurysm recanalisation | Injury, poisoning and procedural complications | MedDRA23.0 | Non-systematic Assessment |
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| Vascular access site thrombosis | Injury, poisoning and procedural complications | MedDRA23.0 | Non-systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA23.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ruptured cerebral aneurysm | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
| |
| Cerebral aneurysm perforation | Nervous system disorders | MedDRA23.0 | Non-systematic Assessment |
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Authorship will be determined prior to development of any manuscript. All information concerning the study device, Sponsor operations, patent application, manufacturing processes, and basic scientific data supplied by the Sponsor to the investigator and not previously published, are considered confidential and remain the sole property of the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cerenovus Clinical Research Director | CERENOVUS | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2025 | Jun 12, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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