Aortic Aneurysm Clinical Trial
Official title:
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
Verified date | July 2023 |
Source | Fuji Systems Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 149 |
Est. completion date | February 1, 2024 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Universita¨tsklinikum Frankfurt | Frankfurt | Theodor-Stern-Kai 7, |
Germany | Universita¨tsklinikum Freiburg | Freiburg | Campus Freiburg: Hugstetter Straße 55 |
Germany | Herzzentrum Leipzig GmbH | Leipzig | Universita¨tsklinik Fu¨r Herzchirurgie Stru¨mpellstraße 39 |
Netherlands | St.Antonius Hospital | Nieuwegein | Koekoekslaan 1, 3435 CN |
Netherlands | Radboud universitair medisch centrum | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Fuji Systems Corporation | Avania |
Germany, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The nature, severity and incidence of adverse events at 30-days post-procedure | 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 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. | |
Other | The collection of an intraoperative parameters(Number of catheter dislocations from target artery (Units)) | Number(Units) of catheter dislocations from target artery will be assessed as exploratory 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. | |
Other | The collection of an intraoperative parameters(Near-infrared spectroscopy (O2 saturation)) | Near-infrared spectroscopy (O2 saturation) will be assessed as exploratory 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. | |
Other | The collection of an intraoperative parameters (Perfusion pressure (mmHg)) | 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 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. | |
Other | The collection of an intraoperative parameters (Circulatory arrest time (minutes)) | Circulatory arrest time(minutes) will be assessed as exploratory 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. | |
Other | The collection of an intraoperative parameters (Selective cerebral perfusion time (minutes)) | Selective cerebral perfusion time (minutes) will be assessed as exploratory 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. | |
Other | The collection of an intraoperative parameters(Perfusion flow rate (mL/kg/min) (maximum and minimum)) | Perfusion flow rate (mL/kg/min) (maximum and minimum) will be assessed as exploratory 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. | |
Other | The collection of an intraoperative parameters(Degree of hypothermia (degrees Celsius)) | 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]) |
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. | |
Primary | "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 | 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 | "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. | 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. |
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