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CompletedNCT04187573CAFIUpdated Nov 20, 2024Results posted

Coil Assisted Flow Diversion Safety and Performance Study

An interventional study of Neqstent in Intracranial Aneurysm, sponsored by Cerus Endovascular, Inc.. Completed at 7 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Cerus Endovascular, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Intracranial Aneurysm

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03

In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 114 are open to participants now.

This study's enrollment of 38 is below the median of 115 across 206 interventional studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Cerus Endovascular, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
38 participants (actual)

Interventions

  • DeviceNeqstent

    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.

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What researchers measure

Primary outcomes

  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 Proportion of Subjects With Complete Occlusion

    Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.

    Time frame: 6 months

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Results

Posted Oct 23, 2024

Participant flow

Participant flow — Overall Study
MilestoneIntervention/Neqstent
Started38
Completed32
Not completed6

Outcome measures

PrimaryThe 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
Reported as:
Count of participants · Participants
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.
ParticipantsIntervention/Neqstent
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.2
PrimaryThe Proportion of Subjects With Complete Occlusion

Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.

Time frame:
6 months
Reported as:
Count of participants · Participants
The Proportion of Subjects With Complete Occlusion
ParticipantsIntervention/Neqstent
The Proportion of Subjects With Complete Occlusion26

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention/Neqstent1/37 (2.7%)15/37 (40.5%)19/37 (51.4%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventIntervention/Neqstent
StrokeNervous system disorders7/37
Non-index Aneurysm TreatmentNervous system disorders2/37
Aneurysm ReccurenceNervous system disorders1/37
HeadacheNervous system disorders1/37
DepressionPsychiatric disorders1/37
Shoulder InjuryInjury, poisoning and procedural complications1/37
Distal Embolic PhenomenonNervous system disorders1/37
Hemorrhagic StrokeNervous system disorders1/37
Device MovementInvestigations1/37
SeizureNervous system disorders1/37
Most frequent other events
Showing 10 of 18
Most frequent other events
EventIntervention/Neqstent
Access Site - HematomaVascular disorders4/37
HeadacheNervous system disorders4/37
Headache and NosebleedNervous system disorders1/37
StrokeNervous system disorders1/37
Disorientation with trouble speakingGeneral disorders1/37
TinnitusNervous system disorders1/37
Dental SurgerySurgical and medical procedures1/37
Radiation induced epilationSkin and subcutaneous tissue disorders1/37
VomitingGeneral disorders1/37
Femoral Artery DissectionInjury, poisoning and procedural complications1/37

Baseline characteristics

All patients; 38 patients were listed in the Participant Flow, and all 38 patients were included in the population description.

Age, Categorical
Age, Categorical(Participants)Intervention/Neqstent
<=18 years0
Between 18 and 65 years26
>=65 years12
Sex: Female, Male
Sex: Female, Male(Participants)Intervention/Neqstent
Female28
Male10
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention/Neqstent
American Indian or Alaska Native1
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White36
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Intervention/Neqstent
Canada5
Austria2
Denmark17
Switzerland1
Germany13
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Study locations

7 sites
  • Christian Doppler Klinikum
    Salzburg, Austria
  • Alberta Health Sciences
    Edmonton, Alberta, Canada
  • Odense University Hospital
    Odense, 5000, Denmark
  • UK Hamburg
    Hamburg, Germany
  • UKSH Kiel
    Kiel, Germany
  • Klinikum der Universität München
    Munich, D-81377, Germany
  • Inerespital Basel
    Basel, Switzerland
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References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 15, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04187573
Lead sponsor
Cerus Endovascular, Inc.
Responsible party
Sponsor
First posted
Dec 5, 2019
Start date
Jan 21, 2020
Primary completion
Jun 17, 2022
Completion
Nov 1, 2023
Results posted
Oct 23, 2024
Last update
Nov 20, 2024

Study contacts

Thomas Liebig, MD
principal investigator · Klinikum der Universität München

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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