We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Coil Assisted Flow Diversion Safety and Performance Study (CAFI)

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: NCT04187573
Recruitment Status : Active, not recruiting
First Posted : December 5, 2019
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Cerus Endovascular, Ltd

Brief Summary:

Cerus Endovascular is sponsoring a prospective, single arm, multi-center study to document the safety and performance of Neqstent in adjunctive therapy.

The purpose of the study is to document safety and performance of the Neqstent in adjunctive therapy in treatment for patients with intracranial aneurysms (IA).


Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Neqstent Not Applicable

Detailed Description:
Neqstent is designed as an adjunctive therapy for patients with unruptured and failed bifurcation aneurysm embolizations. Neqstent can be positioned at the neck of the aneurysm with or without existing coils and other embolization products. Embolization coils should be added to fill the dome of the aneurysm after placement of Neqstent.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, single arm, multi-center study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coil Assisted Flow Diversion: A Prospective, Single Arm, Multi-center Study to Assess the Safety and Performance of Neqstent in Adjunctive Therapy (CAFI Study)
Actual Study Start Date : January 21, 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Neqstent
    Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.


Primary Outcome Measures :
  1. The proportion of subjects with death of any non-accidental cause or any major disabling stroke after treatment or major disabling stroke or death due to neurological cause. [ Time Frame: From day 31 to 6 months after treatment ]
  2. The occlusion rate as adjudicated by a core laboratory. [ Time Frame: 6 months ]
    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.


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

Inclusion Criteria:

  1. Patient's indication for treatment of unruptured IAs 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:

  1. Ruptured aneurysm
  2. Patient anatomy or physiology considered unsuitable for endovascular treatment
  3. Any patient anatomy, physiology, existing implants with failed aneurysm embolization that would interfere with the ability for Neqstent to seal at the neck of the aneurysm. (i.e., compacted coils in close proximity to the neck that prevent good apposition of the Neqstent to the wall of the aneurysm, stent and/or stent-like devices whose struts span the aneurysm neck to retain the coil mass that inhibit access and/or successful Neqstent seating at the aneurysm neck, and/or any aneurysm that has a failed device and confirmed thrombus-burden inside the aneurysm sac)
  4. Contraindication for arterial access
  5. Largest measured IA neck diameter >8 mm or <3 mm
  6. Target IA contains other devices/implants (e.g., coils) that will prevent complete expansion of Neqstent
  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 women of childbearing potential not on adequate birth control (only women with a highly effective method of contraception [oral contraception or intra-uterine device] or sterile women can be enrolled to the study)
  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
  18. The presence of condition that may create unacceptable risk during the aneurysm embolization procedure

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): NCT04187573


Locations
Layout table for location information
Austria
Christian Doppler Klinikum
Salzburg, Austria
Canada, Alberta
Alberta Health Sciences
Edmonton, Alberta, Canada
Denmark
Odense University Hospital
Odense, Denmark, 5000
Germany
UK Hamburg
Hamburg, Germany
UKSH Kiel
Kiel, Germany
Klinikum der Universität München
Munich, Germany, D-81377
Switzerland
Inerespital Basel
Basel, Switzerland
Sponsors and Collaborators
Cerus Endovascular, Ltd
Investigators
Layout table for investigator information
Principal Investigator: Thomas Liebig, MD Klinikum der Universität München
Additional Information:
Layout table for additonal information
Responsible Party: Cerus Endovascular, Ltd
ClinicalTrials.gov Identifier: NCT04187573    
Other Study ID Numbers: DNQS428-01
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: January 27, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases