Trial Outcomes & Findings for Pilot Study of the Contour Neurovascular SystemTM (NCT NCT02784431)

NCT ID: NCT02784431

Last Updated: 2022-07-26

Results Overview

Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.

• Recruitment status: TERMINATED
• Target enrollment: 20 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-07-26

Participant Flow

Participant milestones

Measure	Treated Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Overall Study STARTED	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Measure	Treated Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Overall Study Unsuccessful Implant Attempt	1
Overall Study Early Study Termination	19

Baseline Characteristics

Pilot Study of the Contour Neurovascular SystemTM

Baseline characteristics by cohort

Measure	Treated n=20 Participants Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Age, Continuous	65 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Turkish	2 Participants n=5 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants
Region of Enrollment Hungary	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Patients who were successfully implanted with the Contour device.

Percentage of subjects with major ipsilateral stroke/SAH or death due to neurologic cause within six (6) months after treatment. All neurological events were adjudicated by an independent Medical Monitor.

Outcome measures

Measure	Treated n=19 Participants Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.	0 Participants

SECONDARY outcome

Timeframe: 6 months (3 patients), 1 year (14 patients), 2 year (2 patients)

Population: Patients successfully implanted with the Contour device.

Last known occlusion status of the target IA as judged by an independent core laboratory using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).

Outcome measures

Measure	Treated n=19 Participants Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Occlusion Status of the Target IA Class 2	3 Participants
Occlusion Status of the Target IA Class 1	11 Participants
Occlusion Status of the Target IA Class 3	5 Participants

Adverse Events

Treated

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treated n=19 participants at risk Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Nervous system disorders Transient Ischemic Attack	5.3% 1/19 • Number of events 1 • 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).
General disorders Other - Unrelated to device or procedure	10.5% 2/19 • Number of events 2 • 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).
Injury, poisoning and procedural complications Device deployment issue	5.3% 1/19 • Number of events 1 • 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).

Other adverse events

Measure	Treated n=19 participants at risk Patients who met the eligibility criteria and underwent an treatment attempt with the Contour Neurovascular System.
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).
Injury, poisoning and procedural complications Vascular access site pain	5.3% 1/19 • Number of events 1 • 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).
General disorders Other - Not related to device or procedure	47.4% 9/19 • Number of events 19 • 1 year (9 patients), 6 months (5 patients), 6 weeks (4 patients), hospital discharge following index procedure (1 patient).

Additional Information

Lori E Adels, Ph.D.

Cerus Endovascular

Phone: 510-651-4000

Email: lori.adels@cerusendo.com

Results disclosure agreements

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