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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03680742
Recruitment Status : Active, not recruiting
First Posted : September 21, 2018
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Cerus Endovascular, Ltd

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.


Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Contour Neurovascular System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)
Actual Study Start Date : September 18, 2018
Actual Primary Completion Date : July 1, 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Primary Safety Endpoint; The proportion 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. [ Time Frame: From day 31 to 6 months after treatment ]
    The proportion 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.

  2. Primary Performance Endpoint; To demonstrate the occlusion rate on the 6 month angiogram [ Time Frame: 6 months after treatment ]
    To demonstrate the occlusion rate on the 6 month angiogram as adjudicated by a core laboratory. Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680742


Locations
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Austria
Christian-Doppler-Klinik
Salzburg, Austria, 5020
Denmark
Odense University Hospital
Odense, Denmark
Germany
Klinikum Augsburg
Augsburg, Germany, 86156
UKSH Campus Kiel
Kiel, Germany
UKSH Campus Luebeck
Luebeck, Germany
Klinikum der Universitat München
Munich, Germany, 81377
Sponsors and Collaborators
Cerus Endovascular, Ltd
Investigators
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Principal Investigator: Thomas Liebig, MD Ludwig-Maximilians - University of Munich
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Responsible Party: Cerus Endovascular, Ltd
ClinicalTrials.gov Identifier: NCT03680742    
Other Study ID Numbers: DNX-099.D
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases