Coil Assisted Flow Diversion Safety and Performance Study

NCT04187573 | Completed Results DMC FDA Device

• 1 other identifier: DNQS428-01
• Study Type: interventional
• Target: 38
• Locations: 5 countries
• Sites: 7

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).

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Interventions

Neqstent DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Cerus Endovascular, Inc.: lead

Study Sites (7)

Christian Doppler Klinikum

Salzburg, Austria

Location

Alberta Health Sciences

Edmonton, Alberta, Canada

Location

Odense University Hospital

Odense, 5000, Denmark

Location

UK Hamburg

Hamburg, Germany

Location

UKSH Kiel

Kiel, Germany

Location

Klinikum der Universität München

Munich, D-81377, Germany

Location

Inerespital Basel

Basel, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 37419693 DERIVED

Related Links

• Sponsor Web-site

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Vanessa Sarge
• Organization: Cerus Endovascular, part of Stryker Corporation

vanessa.sarge@stryker.com

5103292048

Study Officials

• Thomas Liebig, MD

  Klinikum der Universität München

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single arm, multi-center study.

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 5, 2019
• Study Start: January 21, 2020
• Primary Completion: June 17, 2022
• Study Completion: November 1, 2023
• Last Updated: November 20, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); AU (1); DK (1); CH (1); CA (1)