NCT02784431

Brief Summary

Prospective, single arm, multi centre study to evaluate the safety and performance of the Contour Neurovascular SystemTM in the treatment of intracranial aneurysm (IA)

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

June 23, 2021

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

May 20, 2016

Results QC Date

April 30, 2021

Last Update Submit

July 22, 2022

Conditions

Intracranial Aneurysm

Keywords

BrainIntracranial Aneurysm TreatmentEndovascular TreatmentBrain AneurysmNeurovascular diseasesAneurysmsCerebrovascular DisordersCentral Nervous System DiseasesVascular diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Major Ipsilateral Stroke/SAH or Death Due to Neurologic Cause Within Six (6) Months After Treatment.

    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.

    6 months

Secondary Outcomes (1)

  • Occlusion Status of the Target IA

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

Study Arms (1)

Contour Neurovascular System placement

EXPERIMENTAL

Treatment of intracranial aneurysm with the Contour Neurovascular System device.

Device: Contour Neurovascular System placement

Interventions

Contour Neurovascular System placementDEVICE

Patients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.

Contour Neurovascular System placement

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80 years at screening
  • Unruptured saccular IA in the anterior or posterior circulation with dimensions consistent with Table 2
  • IA appears suitable for Contour Neurovascular SystemTM device Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements Patient able to understand and sign a study-specific informed consent form

You may not qualify if:

  • Ruptured IA
  • Any other IA that requires treatment in the next year
  • IA width \>8.5 or \<2 mm
  • IA neck \>8 or \<2 mm
  • IA minimum height \<4mm
  • IA embolisation would most likely cause stroke
  • Target IA contains other devices/implants (e.g., coils)
  • Inability to access the target IA with the microcatheter
  • Any congenital or iatrogenic coagulopathy
  • Platelet count \<50,000/microliter
  • Known allergy to platinum, nickel or titanium
  • Known allergy to contrast agents
  • Stenosis of the target IA's parent vessel \>50%
  • Taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm
  • Taking any anticoagulants (e.g., warfarin)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial AneurysmAneurysmCerebrovascular DisordersCentral Nervous System DiseasesVascular Diseases

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesBrain DiseasesNervous System DiseasesCardiovascular Diseases

Limitations and Caveats

The study was terminated early by the Sponsor due to slow enrollment and a change in regulatory strategy. Less than 50% of the planned sample size was enrolled and none of the subjects had been followed for the planned 5 years.

Results Point of Contact

Title
Lori E Adels, Ph.D.
Organization
Cerus Endovascular
lori.adels@cerusendo.com
510-651-4000

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 27, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 26, 2022

Results First Posted

June 23, 2021

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share