Trial Outcomes & Findings for Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction (NCT NCT02312856)

Last Updated: 2019-04-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

180 days post procedure

Results posted on

2019-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	PulseRider Subjects 1 year Follow Up
Overall Study STARTED	34
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	PulseRider Subjects 1 year Follow Up
Overall Study Death	1
Overall Study Lost to Follow-up	3

Baseline Characteristics

Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PulseRider n=34 Participants Total Participants
Age, Continuous Age	60.9 year STANDARD_DEVIATION 13.4 • n=99 Participants
Sex: Female, Male Female	29 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants

PRIMARY outcome

Timeframe: 180 days post procedure

Population: One enrolled participant had MRA performed instead of an angiogram and is excluded from Raymond Score analysis.

Outcome measures

Outcome measures
Measure	Safety n=34 Participants Number of affected participants
Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death # participants experienced Neurological Death	0 Participants
Number of Participants Who Achieved a Raymond Score I/II or Experienced Neurological Death # participants who scored Raymond Score I/II	29 Participants

Adverse Events

Number

Serious events: 12 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Number n=34 participants at risk Number of Participants between the procedure and 365 days
Cardiac disorders Death	2.9% 1/34 • Number of events 1 • 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.
Cardiac disorders Stroke	14.7% 5/34 • Number of events 5 • 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.
Nervous system disorders Cauda Equina Syndrome	2.9% 1/34 • Number of events 1 • 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.
Surgical and medical procedures Coil perforation of aneurysm	2.9% 1/34 • Number of events 1 • 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.
Blood and lymphatic system disorders Anemia	2.9% 1/34 • Number of events 1 • 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.
Nervous system disorders Possible seizure	2.9% 1/34 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Leg Fracture	2.9% 1/34 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Weakness	2.9% 1/34 • Number of events 1 • 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.
Vascular disorders Femoral Occlusion	2.9% 1/34 • Number of events 1 • 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.
Blood and lymphatic system disorders Hypotension	2.9% 1/34 • Number of events 1 • 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.

Other adverse events

Other adverse events
Measure	Number n=34 participants at risk Number of Participants between the procedure and 365 days
Vascular disorders Headache	29.4% 10/34 • Number of events 10 • 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.
Psychiatric disorders Depression	5.9% 2/34 • Number of events 2 • 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.
Skin and subcutaneous tissue disorders Itching	2.9% 1/34 • Number of events 1 • 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.
General disorders Nausea	11.8% 4/34 • Number of events 4 • 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.
General disorders Constipation	5.9% 2/34 • Number of events 2 • 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.
General disorders Ecchymosis	5.9% 2/34 • Number of events 2 • 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.
General disorders Hematoma	5.9% 2/34 • Number of events 2 • 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.
General disorders Dizziness	2.9% 1/34 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory problems	20.6% 7/34 • Number of events 7 • 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.
Respiratory, thoracic and mediastinal disorders Shortness of breath	8.8% 3/34 • Number of events 3 • 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.
Infections and infestations Urinary Tract Infection	5.9% 2/34 • Number of events 2 • 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.
General disorders Nose Bleed	2.9% 1/34 • Number of events 1 • 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.

Additional Information

Christopher Hendricks

CERENOVUS

Phone: 415-656-6565

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60