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

Cerus

Status

Completed

Conditions

Intracranial Aneurysm

Treatments

Device: Contour Neurovascular System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03680742

DNX-099.D

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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