Clinical trial NCT03680742: Contour Neurovascular System - European Pre-Market Unruptured Aneurysm
Official title: Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Cerus Endovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 6 months
measure: Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Christian-Doppler-Klinik
city: Odense
country: Denmark
facility: Odense University Hospital
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Kiel
country: Germany
facility: UKSH Campus Kiel
city: Luebeck
country: Germany
facility: UKSH Campus Luebeck
city: Munich
country: Germany
facility: Klinikum der Universitat München
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Thomas Liebig, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.