UnknownNot Applicable

Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair

Germany, Netherlands149 participantsStarted 2022-05-02

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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) Exclusion Criteria: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

"Successful perfusion" defined by flow rate through the catheter (mL/kg/min)

Timeframe: 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.

Trial details

NCT IDNCT05421130

SponsorFuji Systems Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-01

View on ClinicalTrials.gov More Aortic Aneurysm trials