Trial Outcomes & Findings for A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm (NCT NCT03383666)

Last Updated: 2023-06-06

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

21 participants

Primary outcome timeframe

Up to 1 year post procedure

Results posted on

2023-06-06

Participant Flow

Participant milestones

Participant milestones
Measure	PulseRider Aneurysm Neck Reconstruction Device Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Overall Study STARTED	21
Overall Study Implanted With Pulse Rider	18
Overall Study Attempted But Unsuccessful Implantation	3
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	PulseRider Aneurysm Neck Reconstruction Device Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	2

Baseline Characteristics

A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PulseRider Aneurysm Neck Reconstruction Device n=21 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Age, Continuous	60.4 years STANDARD_DEVIATION 10.09 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 year post procedure

Population: 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.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=13 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Number of Participants With Complete Aneurysm Occlusion Without Significant Parent Artery Stenosis or Prior Retreatment Through 1 Year Post-Procedure	10 Participants

PRIMARY outcome

Timeframe: Up to 1 year post procedure

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=17 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
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) Major Ipsilateral Stroke in Downstream Territory	0 Percentage of Participants
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) Neurological Death	0 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=21 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Number of Participants With Technical Success of Successful Implantation of the PulseRider Device	18 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Number of participants with target aneurysms retreatment were reported.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=17 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Number of Participants With Target Aneurysms Retreatment	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: 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.

Number of participants with significant stenosis (\>50%) at implant site were reported.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=13 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Number of Participants With Significant Stenosis (>50%) at Implant Site	0 Participants

SECONDARY outcome

Timeframe: 1 year

Number of participants with adequate aneurysm occlusion were reported.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=13 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Number of Participants With Adequate Aneurysm Occlusion	13 Participants

SECONDARY outcome

Timeframe: 1 year

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PulseRider Aneurysm Neck Reconstruction Device n=12 Participants Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Number of Participants With Modified Rankin Scale (mRS) 0-2	12 Participants

Adverse Events

PulseRider Aneurysm Neck Reconstruction Device

Serious events: 5 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PulseRider Aneurysm Neck Reconstruction Device n=21 participants at risk Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Infections and infestations Pneumonia	9.5% 2/21 • 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).
Blood and lymphatic system disorders Sickle cell anaemia with crisis	4.8% 1/21 • 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).
Injury, poisoning and procedural complications Toxicity to various agents	4.8% 1/21 • 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).
Metabolism and nutrition disorders Hyponatraemia	4.8% 1/21 • 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).
Nervous system disorders Cerebral haemorrhage	4.8% 1/21 • 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).
Psychiatric disorders Suicide attempt	4.8% 1/21 • 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).

Other adverse events

Other adverse events
Measure	PulseRider Aneurysm Neck Reconstruction Device n=21 participants at risk Participants with wide-neck bifurcation intracranial aneurysms were implanted with PulseRider device.
Nervous system disorders Migraine	9.5% 2/21 • 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).
Nervous system disorders Dizziness	4.8% 1/21 • 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).
Nervous system disorders Headache	4.8% 1/21 • 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).
Nervous system disorders Neuralgia	4.8% 1/21 • 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).
Nervous system disorders Tremor	4.8% 1/21 • 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).
Injury, poisoning and procedural complications Corneal abrasion	4.8% 1/21 • 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).
Injury, poisoning and procedural complications Vascular access site haematoma	4.8% 1/21 • 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).
Injury, poisoning and procedural complications Vascular access site haemorrhage	4.8% 1/21 • 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).
Eye disorders Diplopia	9.5% 2/21 • 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).
Eye disorders Eye haemorrhage	4.8% 1/21 • 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).
Infections and infestations Sinusitis	4.8% 1/21 • 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).
Infections and infestations Urinary tract infection	4.8% 1/21 • 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).
Musculoskeletal and connective tissue disorders Muscular weakness	9.5% 2/21 • 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).
Musculoskeletal and connective tissue disorders Arthralgia	4.8% 1/21 • 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).
Psychiatric disorders Confusional state	4.8% 1/21 • 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).
Psychiatric disorders Hallucination, visual	4.8% 1/21 • 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).
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.8% 1/21 • 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).
Respiratory, thoracic and mediastinal disorders Epistaxis	4.8% 1/21 • 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).
General disorders Asthenia	4.8% 1/21 • 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).
Reproductive system and breast disorders Menorrhagia	4.8% 1/21 • 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).

Additional Information

Michael Liao

Cerenovus

Phone: 510-770-5376

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER