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

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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Contour Neurovascular System

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Christian-Doppler-Klinik
• Denmark
  • Odense, Denmark
    • Odense University Hospital
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Kiel, Germany
    • UKSH Campus Kiel
  • Luebeck, Germany
    • UKSH Campus Luebeck
  • Munich, Germany, 81377
    • Klinikum der Universität München

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated; All eligible patients who underwent an attempt with the Contour device.	Device: Contour Neurovascular System; The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months
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).	6 months

Collaborators and Investigators

• Sponsor: Cerus Endovascular, Ltd
• Investigators: Principal Investigator: Thomas Liebig, MD, Ludwig-Maximilians - University of Munich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): August 10, 2020
• Study Completion (Actual): February 2, 2021

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: DNX-099.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No