Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

Intracranial Aneurysm Clinical Trial

— CERUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680742
• Other study ID #: DNX-099.D
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: February 2, 2021

Study information

• Verified date: June 2021
• Source: Cerus Endovascular, Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2, 2021
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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

Locations

Country	Name	City	State
Austria	Christian-Doppler-Klinik	Salzburg
Denmark	Odense University Hospital	Odense
Germany	Klinikum Augsburg	Augsburg
Germany	UKSH Campus Kiel	Kiel
Germany	UKSH Campus Luebeck	Luebeck
Germany	Klinikum der Universitat München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Cerus Endovascular, Ltd

Countries where clinical trial is conducted

Austria,  Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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