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No safety issues; change in innovation strategy
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This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
The objective of this study is to evaluate the safety and effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device in conjunction with coil embolization in the endovascular treatment of unruptured wide-neck intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | PulseRider® Aneurysm Neck Reconstruction in conjunction with coil embolization for unruptured wide-neck intracranial aneurysms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PulseRider® Aneurysm Neck Reconstruction Device | Device | Neck Reconstruction Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure | Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than [>] 50 percent [%] stenosis) or prior retreatment through 1-year post procedure were reported. | Up to 1 year post procedure |
| Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC) | Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (>=) 4. Major ipsilateral stroke is major stroke in downstream territory. | Up to 1 year post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Technical Success of Successful Implantation of the PulseRider Device | Technical success was defined as successful implantation of the PulseRider device- the ability to access the target aneurysm, deploy the device at the aneurysm neck, and detach device successfully. Number of participants with technical success were reported. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States | ||
| Mount Sinai Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | PulseRider Aneurysm Neck Reconstruction Device | Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device. |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 13, 2017 |
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| Number of Participants With Target Aneurysms Retreatment | Number of participants with target aneurysms retreatment were reported. | Up to 1 year |
| Number of Participants With Significant Stenosis (>50%) at Implant Site | Number of participants with significant stenosis (>50%) at implant site were reported. | Up to 1 year |
| Number of Participants With Adequate Aneurysm Occlusion | Number of participants with adequate aneurysm occlusion were reported. | 1 year |
| Number of Participants With Modified Rankin Scale (mRS) 0-2 | Number of participants with modified rankin scale (mRS) 0-2 were reported. The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in patients following stroke or other neurologic event and is conducted by qualified personnel. It is a scale with six categories ranging from no symptoms to severe disability and death. | 1 year |
| New York |
| New York |
| 10029 |
| United States |
| Implanted With Pulse Rider |
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| Attempted But Unsuccessful Implantation |
|
| COMPLETED |
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| NOT COMPLETED |
|
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The modified intent to treat (mITT) analysis set is defined as all enrolled participants in whom treatment with the PulseRider device was attempted as defined by advancement of any portion of the PulseRider device outside of the distal end of the microcatheter inside the participant.
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| ID | Title | Description |
|---|---|---|
| BG000 | PulseRider Aneurysm Neck Reconstruction Device | Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device. |
| 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 |
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| 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 With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure | Number of participants with complete aneurysm occlusion (Raymond I: complete occlusion) without significant parent artery stenosis (greater than [>] 50 percent [%] stenosis) or prior retreatment through 1-year post procedure were reported. | The Per Protocol (PP) analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to 1 year post procedure |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Occurrence of Neurological Death or Major Ipsilateral Stroke in Downstream Territory up to 1 Year Post-procedure Per Clinical Events Committee (CEC) | Percentage of participants with occurrence of neurological death or major ipsilateral stroke in downstream territory up to 1 year post-procedure per CEC were reported. Major stroke is defined as stroke with symptoms persisting for more than 24 hours and a sudden increase in the National Institutes of Health Stroke Scale (NIHSS) of the subject by greater than or equal to (>=) 4. Major ipsilateral stroke is major stroke in downstream territory. | The modified intent to treat (mITT) analysis set is defined as all enrolled participants in whom treatment with the PulseRider device was attempted as defined by advancement of any portion of the PulseRider device outside of the distal end of the microcatheter inside the participant. Here, N (number of participants analyzed) defined as participants evaluable for this outcome measure. | Posted | Number | Percentage of Participants | Up to 1 year post procedure |
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| Secondary | Number of Participants With Technical Success of Successful Implantation of the PulseRider Device | Technical success was defined as successful implantation of the PulseRider device- the ability to access the target aneurysm, deploy the device at the aneurysm neck, and detach device successfully. Number of participants with technical success were reported. | The mITT analysis set is defined as all enrolled participants in whom treatment with the PulseRider device was attempted as defined by advancement of any portion of the PulseRider device outside of the distal end of the microcatheter inside the participant. | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Number of Participants With Target Aneurysms Retreatment | Number of participants with target aneurysms retreatment were reported. | The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations from the eligibility criteria or dual antiplatelet medication. | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Number of Participants With Significant Stenosis (>50%) at Implant Site | Number of participants with significant stenosis (>50%) at implant site were reported. | The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Up to 1 year |
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| Secondary | Number of Participants With Adequate Aneurysm Occlusion | Number of participants with adequate aneurysm occlusion were reported. | The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Modified Rankin Scale (mRS) 0-2 | Number of participants with modified rankin scale (mRS) 0-2 were reported. The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in patients following stroke or other neurologic event and is conducted by qualified personnel. It is a scale with six categories ranging from no symptoms to severe disability and death. | The PP analysis set is defined as all participants successfully implanted with the PulseRider device with no major protocol deviations from the eligibility criteria or dual antiplatelet medication. Here, N (number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 1 year |
|
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From enrollment up to 1 year post procedure.
Modified intent to treat (mITT) analysis set: all enrolled Participants in whom treatment with PulseRider device was attempted. Adverse event data was adjudicated by independent Clinical Events Committee (CEC).
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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 | PulseRider Aneurysm Neck Reconstruction Device | Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device. | 0 | 21 | 5 | 21 | 13 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Toxicity to various agents | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | Non-systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Neuralgia | Nervous system disorders | Non-systematic Assessment |
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| Tremor | Nervous system disorders | Non-systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vascular access site haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Vascular access site haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Diplopia | Eye disorders | Non-systematic Assessment |
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| Eye haemorrhage | Eye disorders | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Confusional state | Psychiatric disorders | Non-systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Asthenia | General disorders | Non-systematic Assessment |
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| Menorrhagia | Reproductive system and breast disorders | Non-systematic Assessment |
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Only 1-year endpoint analyses were performed due to early termination of study enrollment.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Liao | Cerenovus | 510-770-5376 | mliao7@its.jnj.com |
| Mar 22, 2022 |
| Prot_SAP_004.pdf |
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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 |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| 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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