Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

NCT03680742 | Completed Results DMC

• 1 other identifier: DNX-099.D
• Study Type: interventional
• Target: 34
• Locations: 3 countries
• Sites: 6

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Treated

EXPERIMENTAL

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

Device: Contour Neurovascular System

Interventions

Contour Neurovascular System DEVICE

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

Treated

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerus Endovascular, Inc.: lead

Study Sites (6)

Christian-Doppler-Klinik

Salzburg, 5020, Austria

Location

Odense University Hospital

Odense, Denmark

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

UKSH Campus Kiel

Kiel, Germany

Location

UKSH Campus Luebeck

Lübeck, Germany

Location

Klinikum der Universitat München

Munich, 81377, Germany

Location

Related Publications (1)

• 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.

  PMID: 35113830 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Lori E Adels, Ph.D.
• Organization: Cerus Endovascular

lori.adels@cerusendo.com

510-651-4000

Study Officials

• Thomas Liebig, MD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 21, 2018
• Study Start: September 18, 2018
• Primary Completion: August 10, 2020
• Study Completion: February 2, 2021
• Last Updated: June 23, 2021
• Results First Posted: May 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); AU (1); DE (4)