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This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
Primary Endpoints:
Additional Evaluations to 180-days and at 365-day follow up:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PulseRider aneurysm | Experimental | Endovascular treatment of intracranial aneurysms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PulseRider | Device | Adjunctive device for endovascular embolization of intracranial aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death | Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death. | 180 days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Spiotta, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PulseRider | Subjects 1 year Follow Up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Male and female subjects, ≥18 years of age with a wide neck (≥ 4 mm or dome to neck ratio < 2) basilar or carotid terminus aneurysm located at a bifurcation. Subjects with acutely ruptured aneurysms were excluded from the study. The aneurysm parent vessel measurements were required to be between 2.7 mm and 4.5 mm to be suitable for the procedure.
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| ID | Title | Description |
|---|---|---|
| BG000 | PulseRider | Total Participants |
| 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 | Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death | Raymond Scale- an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. Achieving a Raymond Score I/II. class I: complete obliteration class II: residual neck class III: residual aneurysm class IIIa: contrast opacification within the coil interstices of a residual aneurysm class IIIb: contrast opacification outside the coil interstices, along the residual aneurysm wall. Raymond I is typically associated with better outcomes. The primary outcome of the study looked at safety (death or stroke) and Rate of Aneurysm occlusion (assess by Raymond Roy scores) the two are different. The RR Score is an assessment of occlusion and not used to assess death. | One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis. | Posted | Number | Participants | 180 days post procedure |
|
AEs and SAEs were collected from enrollment of the first subject through 1 year for all subjects.
All AEs and SAEs were included in the reports to FDA throughout the study.
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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 | Number | Number of Participants between the procedure and 365 days | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Standard terminology | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Vascular disorders | Standard terminology | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Hendricks | CERENOVUS | 415-656-6565 | chendric@its.jnj.com |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Number of affected participants |
|
|
| 34 |
| 12 |
| 34 |
| 27 |
| 34 |
| Stroke | Cardiac disorders | Standard terminology | Systematic Assessment |
|
| Cauda Equina Syndrome | Nervous system disorders | Standard terminology | Systematic Assessment |
|
| Coil perforation of aneurysm | Surgical and medical procedures | Standard terminology | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Standard terminology | Systematic Assessment |
|
| Possible seizure | Nervous system disorders | Standard terminology | Systematic Assessment |
|
| Leg Fracture | Musculoskeletal and connective tissue disorders | Standard terminology | Systematic Assessment |
|
| Weakness | Musculoskeletal and connective tissue disorders | Standard terminology | Systematic Assessment | Right or left side weakness |
|
| Femoral Occlusion | Vascular disorders | Standard terminology | Systematic Assessment |
|
| Hypotension | Blood and lymphatic system disorders | Standard terminology | Systematic Assessment | Hypotension |
|
| Depression | Psychiatric disorders | Standard terminology | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Standard terminology | Systematic Assessment |
|
| Nausea | General disorders | Standard terminology | Systematic Assessment |
|
| Constipation | General disorders | Standard terminology | Systematic Assessment |
|
| Ecchymosis | General disorders | Standard terminology | Systematic Assessment |
|
| Hematoma | General disorders | Standard terminology | Systematic Assessment |
|
| Dizziness | General disorders | Standard terminology | Systematic Assessment |
|
| Respiratory problems | Respiratory, thoracic and mediastinal disorders | Standard terminology | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Standard terminology | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Standard terminology | Systematic Assessment |
|
| Nose Bleed | General disorders | Standard terminology | Systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |