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Contour Neurovascular System - European Pre-Market Unruptured Aneurysm (CERUS)

Primary Purpose

Intracranial Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Contour Neurovascular System
Sponsored by
Cerus Endovascular, Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients of all genders who meet all indications and contraindications will proceed to implantation.

Inclusion criteria

  1. Patient's indication for treatment of unruptured aneurysm is according to the national/international guidelines.
  2. Age 18-80 years at screening
  3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs
  4. IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU
  5. 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
  6. Patient able to able to give their informed consent can be included in this study. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.

Exclusion criteria

The presence of condition that may create unacceptable risk during the aneurysm embolization procedure, such as patients with:

  1. Ruptured aneurysm
  2. Patient anatomy or physiology considered unsuitable for endovascular treatment
  3. Contraindication for arterial access
  4. Largest measured IA equatorial diameter >8.5 mm or <2 mm
  5. Largest measured IA neck diameter >8 mm or <2 mm
  6. Target IA contains other devices/implants (e.g., coils)
  7. Known allergy to platinum, nickel or titanium
  8. Known allergy to contrast agents
  9. Contraindication to anticoagulants or platelet inhibitor medication
  10. Stenosis of the target IA's parent vessel >50%
  11. Anticoagulation medications such as warfarin that cannot be discontinued
  12. Pregnant, breastfeeding or planning pregnancy in the next 2 years
  13. Acute / chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 μmol/L
  14. Myocardial Infarction, Stroke or TIA within the last 6 months
  15. Any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc.
  16. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.)
  17. Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes

Sites / Locations

  • Christian-Doppler-Klinik
  • Odense University Hospital
  • Klinikum Augsburg
  • UKSH Campus Kiel
  • UKSH Campus Luebeck
  • Klinikum der Universitat München

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treated

Arm Description

All eligible patients who underwent an attempt with the Contour device.

Outcomes

Primary Outcome Measures

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.
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.
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months.
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).

Secondary Outcome Measures

Full Information

First Posted
September 18, 2018
Last Updated
June 22, 2021
Sponsor
Cerus Endovascular, Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03680742
Brief Title
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
Acronym
CERUS
Official Title
Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
February 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerus Endovascular, Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour"). The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.
Detailed Description
Contour Neurovascular System™ European Pre-Market Unruptured Aneurysm Study (CERUS) initiated enrollment in October 2018 to assess the safety and effectiveness of the Contour Neurovascular System ("Contour") in treatment of intracranial aneurysms (IA) with the intended indication for endovascular embolization of saccular IA. This prospective, single-arm, multicenter study was conducted to document the safety and performance of the Contour in treatment for patients with an IA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treated
Arm Type
Experimental
Arm Description
All eligible patients who underwent an attempt with the Contour device.
Intervention Type
Device
Intervention Name(s)
Contour Neurovascular System
Intervention Description
The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
6 months
Title
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months.
Description
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).
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients of all genders who meet all indications and contraindications will proceed to implantation. Inclusion criteria Patient's indication for treatment of unruptured aneurysm is according to the national/international guidelines. Age 18-80 years at screening Patients who are suitable for non-emergency endovascular embolization of saccular IAs IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU 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 able to give their informed consent can be included in this study. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study. Exclusion criteria The presence of condition that may create unacceptable risk during the aneurysm embolization procedure, such as patients with: Ruptured aneurysm Patient anatomy or physiology considered unsuitable for endovascular treatment Contraindication for arterial access Largest measured IA equatorial diameter >8.5 mm or <2 mm Largest measured IA neck diameter >8 mm or <2 mm Target IA contains other devices/implants (e.g., coils) Known allergy to platinum, nickel or titanium Known allergy to contrast agents Contraindication to anticoagulants or platelet inhibitor medication Stenosis of the target IA's parent vessel >50% Anticoagulation medications such as warfarin that cannot be discontinued Pregnant, breastfeeding or planning pregnancy in the next 2 years Acute / chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 μmol/L Myocardial Infarction, Stroke or TIA within the last 6 months Any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.) Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Liebig, MD
Organizational Affiliation
Ludwig-Maximilians - University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christian-Doppler-Klinik
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
UKSH Campus Kiel
City
Kiel
Country
Germany
Facility Name
UKSH Campus Luebeck
City
Luebeck
Country
Germany
Facility Name
Klinikum der Universitat München
City
Munich
ZIP/Postal Code
81377
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35113830
Citation
Liebig T, Killer-Oberpfalzer M, Gal G, Schramm P, Berlis A, Dorn F, Jansen O, Fiehler J, Wodarg F. The Safety and Effectiveness of the Contour Neurovascular System (Contour) for the Treatment of Bifurcation Aneurysms: The CERUS Study. Neurosurgery. 2022 Mar 1;90(3):270-277. doi: 10.1227/NEU.0000000000001783. Epub 2021 Dec 29.
Results Reference
derived

Learn more about this trial

Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

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