Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: SP-GRIPFLOW 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. |
Device: Selective Cerebral Perfusion Catheter
This product is intended to be placed in the branches of the aortic arch for the cerebral perfusion during surgery of aorta.
Other Names:
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Outcome Measures
Primary Outcome Measures
- "Successful perfusion" defined by flow rate through the catheter (mL/kg/min) [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.]
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
Secondary Outcome Measures
- "Adequate flow rate" assessed by a clinically relevant through the catheter(mean and maximum flow rate「mL/kg/min」). endpoints [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.]
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.
Other Outcome Measures
- The nature, severity and incidence of adverse events at 30-days post-procedure [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.]
The safety of the SP-GRIPFLOW Catheter will be assessed by the nature, severity and incidence of adverse events at 30-days post-procedure. The adverse events found for the SP-GRIPFLOW will be compared to the current knowledge and state of the art to assess whether the device is associated with acceptable safety outcomes. No formal hypothesis testing will be performed for the safety endpoint of this clinical investigation.
- The collection of an intraoperative parameters(Number of catheter dislocations from target artery (Units)) [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.]
Number(Units) of catheter dislocations from target artery will be assessed as exploratory endpoints.
- The collection of an intraoperative parameters(Near-infrared spectroscopy (O2 saturation)) [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.]
Near-infrared spectroscopy (O2 saturation) will be assessed as exploratory endpoints.
- The collection of an intraoperative parameters (Perfusion pressure (mmHg)) [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.]
Perfusion pressure (mmHg) will be assessed as exploratory endpoints. Perfusion pressure is interpreted as below items. Line pressure Pressure at the tip of SP-GRIPFLOW (if available) Radial blood pressure, left and right
- The collection of an intraoperative parameters (Circulatory arrest time (minutes)) [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.]
Circulatory arrest time(minutes) will be assessed as exploratory endpoints.
- The collection of an intraoperative parameters (Selective cerebral perfusion time (minutes)) [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.]
Selective cerebral perfusion time (minutes) will be assessed as exploratory endpoints.
- The collection of an intraoperative parameters(Perfusion flow rate (mL/kg/min) (maximum and minimum)) [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.]
Perfusion flow rate (mL/kg/min) (maximum and minimum) will be assessed as exploratory endpoints.
- The collection of an intraoperative parameters(Degree of hypothermia (degrees Celsius)) [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.]
Degree of hypothermia (degrees Celsius) will be assessed as exploratory endpoints. (tympanic membrane or nasal temperature [for cerebral perfusion temperature measurement] and any of followings if available: rectal temperature, bladder temperature, or esophageal temperature [for systemic circulation temperature measurement])
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects shall fulfil all of the following criteria:
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Is willing and able to understand and sign informed consent, and has signed an information and inform consent
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Is male or female
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Is minimum 18 years of age when signing the informed consent
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Has been diagnosed with an aortic arch aneurysm or chronic dissection with an indication for open arch repair
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Is indicated for elective open/hybrid aortic arch repair with cerebral perfusion
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Is willing and able to comply to the schedule of assessment of the clinical investigation
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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:
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Aortic dissection or rupture which requires acute surgery
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Emergency surgery
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American Society of Anesthesiologists (ASA) Class >IV
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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.
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Had cerebral perfusion with another similar device/competitor device
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St.Antonius Hospital | Nieuwegein | Koekoekslaan 1, 3435 CN | Netherlands |
Sponsors and Collaborators
- Fuji Systems Corporation
- Avania
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NL73323.100.21