Post Market Clinical Follow-up (PMCF)Study of the Contour Neurovascular SystemTM

Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.

Study Overview

• Status: Withdrawn
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Contour Neurovascular System

Detailed Description

The primary objective of this study is to document the safety and performance of the "Contour Neurovascular System™. The data from the study will be reported as a Post Market study to the Notified Body as part of the Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plan.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with enraptured bifurcated intracranial aneurysms.

Description

Inclusion Criteria:

• 1. Patient indicated for treatment of a single, unruptured aneurysm is according to the national/international guidelines.

  2. Age 18 years or older at screening. 3. Patient 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 for Contour.

  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 is able to give their informed consent. 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

  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 that could interfere with proper placement of the Contour device (e.g., coils).
  7. Known allergy to platinum, nickel or titanium.
  8. Known allergy or intolerance to contrast agents.
  9. Contraindication to anticoagulants or platelet inhibitor medication.
  10. In the opinion of the investigator, 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.
  11. 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, substance abuse and hematologic disorders etc.).
  12. Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes.
  13. The presence of a condition that may create unacceptable risk during the aneurysm embolization procedure.
  14. Female patient who is pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with non-accidental death cause or any major ipsilateral stroke within the first 30 days after treatment or major ipsilateral stroke or death due to neurological cause from day 31 to final follow-up visit per standard of care).	Primary Safety Endpoint	1 year
Aneurysm occlusion rate on the follow-up angiogram as reported by the investigator." "Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy (RR) Scale.	Primary Performance Endpoint	1 year

Collaborators and Investigators

• Sponsor: Cerus Endovascular, Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: DNX090-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No