Aortic AneurysmNCT05421130
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
A study testing Selective Cerebral Perfusion Catheter in people with Aortic Aneurysm and Aortic Dissection, run by Fuji Systems Corporation at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions. The information from this research will be used to help decide if the device should be approved for sale in the European Union. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm
- What is being tested?
- Selective Cerebral Perfusion Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 May 2022to 1 Feb 2024
- Phase
- Interventional
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects shall fulfil all of the following criteria:
- Is willing and able to understand and sign informed consent, and has signed an information and inform consent
- Is male or female
- Is minimum 18 years of age when signing the informed consent
- Has been diagnosed with an aortic arch aneurysm or chronic dissection with an indication for open arch repair
- Is indicated for elective open/hybrid aortic arch repair with cerebral perfusion
- Is willing and able to comply to the schedule of assessment of the clinical investigation
- Has a target vessel diameter appropriate for the use of the SPGRIPFLOW Catheter (12Fr, 14Fr or16Fr)
Who cannot join
- Subjects shall fulfil none of the following criteria:
- Aortic dissection or rupture which requires acute surgery
- Emergency surgery
- American Society of Anesthesiologists (ASA) Class >IV
- Is currently participating in, or has recently exited from (within 30 days prior to screening for this clinical investigation), or plans to be enrolled (during the course of this clinical investigation) in another clinical investigation that may affect the endpoints of this clinical investigation.
- Had cerebral perfusion with another similar device/competitor device
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany3 sites
Universitätsklinikum Frankfurt
Frankfurt, Theodor-Stern-Kai 7,, 60590
Universitätsklinikum Freiburg
Freiburg im Breisgau, Campus Freiburg: Hugstetter Straße 55, 79106
Herzzentrum Leipzig GmbH
Leipzig, Universitätsklinik Für Herzchirurgie Strümpellstraße 39, 04289
Netherlands2 sites
St.Antonius Hospital
Nieuwegein, Koekoekslaan 1, 3435 CN
Radboud universitair medisch centrum
Nijmegen, 6500HB
About this study
The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions. The information from this research will be used to help decide if the device should be approved for sale in the European Union. The SP-GRIPFLOW catheter may not yet be used by investigators outside of the study.
Through the study, FUJI will prove that the target flow as measured by the flow through the catheter(s)(cumulative flow for multiple catheters) was confirmed in 95% of cases.
Read the detailed description
The SP-GRIPFLOW catheter is a catheter that is used to transport blood from the aortic arch to your brain during surgery on the aorta. The procedure in which the catheter is used does not differ from the procedure as performed with current catheters. Furthermore, the SP-GRIPFLOW catheter is used in a similar manner as other catheters that are currently on the market. Contrary to available catheters, the SP-GRIPFLOW has a ribbed surface on the balloon end of the device, which aims to improve the grip of the balloon in order to reduce chances of dislocation from the target artery.
Clinical trials are needed to obtain or expand knowledge about the safety, suitability and effi-cacy of medical devices. This is why the legislative authority has specified in the law on medi-cal devices that new medical devices must be clinically tested. The clinical trial that we present to you here was - as required by law - granted a favourable opinion by an ethics committee and approved by the competent authority. This clinical trial will be conducted at up to 5 sites in the European Union; a total of approximately 149 persons will participate in it. The study is being initiated, organised, and financed by Fuji Systems Corporation, the sponsor of this study.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm, Aortic Arch; Aneurysm, Dissecting
- Being tested
- Selective Cerebral Perfusion Catheter
- Medical subject headings
- Aortic Aneurysm, Aortic Dissection, Aneurysm, Aortic Arch, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Cerebral Perfusion CatheterDevice
Also called SP-GRIPFLOW
This product is intended to be placed in the branches of the aortic arch for the cerebral perfusion during surgery of aorta.
| Study group | Role | What they receive |
|---|---|---|
| SP-GRIPFLOW | Other | This is a single-arm clinical investigation. Enrolled subjects will have cerebral perfusion with the investigational device during surgical repair of the aortic arch. A total of 1-3 investigational devices will be used per subject. Receives: Device: Selective Cerebral Perfusion Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Successful perfusion" defined by flow rate through the catheter (mL/kg/min)
The primary endpoint is defined by blood flow through the SPGRIPFLOW and perfusion of the brain during open surgical repair of the distal aortic arch. Blood flow (and perfusion) is assessed by the flow rate through the cannula(s) compared to the target flow rate. Successful perfusion is defined when the flow rate through the catheter(s) equals the target flow rate (mL/kg/min). The perfusion flow rate will be monitored throughout the procedure. The target flow rate will be preoperatively defined by the investigator
Measured: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
Secondary outcomes (1)
"Adequate flow rate" assessed by a clinically relevant through the catheter(mean and maximum flow rate「mL/kg/min」). endpoints
The secondary endpoint of this study will focus on assessment of adequate flow rate through the SP-GRIPFLOW. Whether the SPGRIPFLOW allows for an adequate flow rate will be assessed by a clinically relevant flow through the catheter(s) (mean and maximum flow rate). A clinically relevant perfusion flow rate of 10-15 mL/min/kg was defined from scientific literature.
Measured: The enrolment period is expected to take approximately 15 months. The duration of the subject's participation is circa 1 month. The total expected duration of the clinical investigation is, therefore, approximately 16 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2022
- Study start2 May 2022
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic 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
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuji Systems Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05421130
- Sponsor's protocol ID
- NL73323.100.21
- Status last verified
- Jul 2023
- First submitted
- 22 Apr 2022
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No