Intracranial AneurysmCAFINCT04187573
Coil Assisted Flow Diversion Safety and Performance Study
A study testing Neqstent in people with Intracranial Aneurysm, run by Cerus Endovascular, Inc. at 7 sites in 5 countries.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Neqstent
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 21 Jan 2020to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's indication for treatment of unruptured IAs 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.
Who cannot join
- Ruptured aneurysm
- Patient anatomy or physiology considered unsuitable for endovascular treatment
- 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)
- Contraindication for arterial access
- Largest measured IA neck diameter >8 mm or <3 mm
- Target IA contains other devices/implants (e.g., coils) that will prevent complete expansion of Neqstent
Show all 18Show fewer
- 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 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)
- 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
- 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.
- 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.)
- Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes
- The presence of condition that may create unacceptable risk during the aneurysm embolization procedure
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany3 sites
UK Hamburg
Hamburg
UKSH Kiel
Kiel
Klinikum der Universität München
Munich, D-81377
About this study
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)
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.
- Conditions
- Intracranial Aneurysm
- Being tested
- Neqstent
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeqstentDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day 31 to 6 months after treatment
The Proportion of Subjects With Complete Occlusion
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start21 Jan 2020
- Primary completion17 Jun 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm, multi-center study.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Endovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Liebig, MD, Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187573
- Sponsor's protocol ID
- DNQS428-01
- Acronym
- CAFI
- Status last verified
- Oct 2024
- First submitted
- 27 Nov 2019
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Liebig T, Gal G, O Kelly C, Wodarg F, Killer-Oberpfalzer M, Ozpeynirci Y, Bester M, Tsogkas I, Psychogios MN, Jansen O, Fiehler J. Neqstent coil-assisted flow diverter (NQS) for the treatment of bifurcation aneurysms: the coil-assisted flow diversion safety and performance study (CAFI). J Neurointerv Surg. 2024 Jun 17;16(7):721-725. doi: 10.1136/jnis-2022-020056.
PubMed 37419693
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04187573
- Acronym / sponsor ID
- CAFI / DNQS428-01
- Conditions
- Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cerus Endovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 17 Jun 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Prospective, single arm, multi-center study.
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient's indication for treatment of unruptured IAs 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
Key exclusion criteria (18 listed)
- Ruptured aneurysm
- Patient anatomy or physiology considered unsuitable for endovascular treatment
- 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)
- Contraindication for arterial access
- Largest measured IA neck diameter >8 mm or <3 mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeqstentAdjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm. | Device | – |
Primary outcome
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
The Proportion of Subjects With Complete Occlusion
Time frame: 6 months
Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37419693Liebig T, Gal G, O Kelly C, Wodarg F, Killer-Oberpfalzer M, Ozpeynirci Y, Bester M, Tsogkas I, Psychogios MN, Jansen O, Fiehler J. Neqstent coil-assisted flow diverter (NQS) for the treatment of bifurcation aneurysms: the coil-assisted flow diversion safety and performance study (CAFI). J Neurointerv Surg. 2024 Jun 17;16(7):721-725. doi: 10.1136/jnis-2022-020056.
- Sponsor Web-siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Liebig, MD principal investigator
LMU Klinikum
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neqstent in people with Intracranial Aneurysm, run by Cerus Endovascular, Inc. at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Austria, Canada, Denmark, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.