Trial Outcomes & Findings for Contour Neurovascular System - European Pre-Market Unruptured Aneurysm (NCT NCT03680742)

Results Overview

The Primary Safety Endpoint is the percentage of subjects with death of any non-accidental cause or any major disabling stroke within the first 30 days after treatment or major disabling stroke or death due to neurological cause from day 31 to 6 months after treatment. Major Disabling Stroke is defined as an episode of neurological signs or symptoms that persist beyond 24 hours accompanied with evidence of ischemia/infarction on imaging that results in an increase of NIHSS from baseline by \>= 4 points and/or an increase from mRS baseline by \>2. An independent Clinical Events Committee adjudicated all data used for safety endpoint analyses.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

6 months

Results posted on

2021-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treated All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treated All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Overall Study Unsuccessful Implant Attempt	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated n=34 Participants All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Age, Continuous	58.0 years STANDARD_DEVIATION 11.2 • n=34 Participants
Sex: Female, Male Female	15 Participants n=34 Participants
Sex: Female, Male Male	19 Participants n=34 Participants
Region of Enrollment Austria	6 participants n=34 Participants
Region of Enrollment Denmark	6 participants n=34 Participants
Region of Enrollment Germany	22 participants n=34 Participants

PRIMARY outcome

Timeframe: 6 months

The Primary Safety Endpoint is the percentage of subjects with death of any non-accidental cause or any major disabling stroke within the first 30 days after treatment or major disabling stroke or death due to neurological cause from day 31 to 6 months after treatment. Major Disabling Stroke is defined as an episode of neurological signs or symptoms that persist beyond 24 hours accompanied with evidence of ischemia/infarction on imaging that results in an increase of NIHSS from baseline by \>= 4 points and/or an increase from mRS baseline by \>2. An independent Clinical Events Committee adjudicated all data used for safety endpoint analyses.

Outcome measures

Outcome measures
Measure	Treated n=34 Participants All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment.	1 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Subjects with 6-month cerebral angiograms assessed by the core laboratory.

The Primary Performance Endpoint was the percentage of subjects with complete aneurysm occlusion at 6 months as adjudicated by an independent core laboratory. Occlusion was assessed using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).

Outcome measures

Outcome measures
Measure	Treated n=29 Participants All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. Class 1	14 Participants
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. Class 2	9 Participants
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months. Class 3	6 Participants

Adverse Events

Treated

Serious events: 13 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treated n=34 participants at risk All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Nervous system disorders Seizure	2.9% 1/34 • Number of events 1 • 1 year (32 subjects); 1 month (2 subjects)
Nervous system disorders Stroke	23.5% 8/34 • Number of events 10 • 1 year (32 subjects); 1 month (2 subjects)
Nervous system disorders Thrombus	2.9% 1/34 • Number of events 1 • 1 year (32 subjects); 1 month (2 subjects)
General disorders Other - Procedure related	14.7% 5/34 • Number of events 5 • 1 year (32 subjects); 1 month (2 subjects)
General disorders Other - Not related to device or procedure	8.8% 3/34 • Number of events 5 • 1 year (32 subjects); 1 month (2 subjects)

Other adverse events

Other adverse events
Measure	Treated n=34 participants at risk All eligible patients who underwent an attempt with the Contour device. Contour Neurovascular System: The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Nervous system disorders Transient Ischemic Attack	2.9% 1/34 • Number of events 1 • 1 year (32 subjects); 1 month (2 subjects)
General disorders Other - Not related to device or procedure	23.5% 8/34 • Number of events 12 • 1 year (32 subjects); 1 month (2 subjects)

Additional Information

Lori E Adels, Ph.D.

Cerus Endovascular

Phone: 510-651-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place