Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

NCT ID: NCT03680742

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2021-02-02

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.

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treated

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

Group Type: EXPERIMENTAL

Contour Neurovascular System

Intervention Type: DEVICE

The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.

Interventions

Contour Neurovascular System

The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerus Endovascular, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Liebig, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

Christian-Doppler-Klinik

Salzburg, , Austria

Odense University Hospital

Odense, , Denmark

Klinikum Augsburg

Augsburg, , Germany

UKSH Campus Kiel

Kiel, , Germany

UKSH Campus Luebeck

Lübeck, , Germany

Klinikum der Universitat München

Munich, , Germany

Countries

Austria; Denmark; Germany

References

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.

Reference Type: DERIVED

PMID: 35113830 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DNX-099.D

Identifier Type: -

Identifier Source: org_study_id