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| Name | Class |
|---|---|
| Avania | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective Cerebral Perfusion Catheter | Device | This product is intended to be placed in the branches of the aortic arch for the cerebral perfusion during surgery of aorta. |
|
| Measure | Description | Time Frame |
|---|---|---|
| "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. |
| Measure | Description | Time Frame |
|---|---|---|
| "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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Subjects shall fulfil all of the following criteria:
Exclusion Criteria:
Subjects shall fulfil none of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Campus Freiburg: Hugstetter Straße 55 | 79106 | Germany | ||
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|
| 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 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Universitätsklinikum Frankfurt |
| Frankfurt |
| Theodor-Stern-Kai 7, |
| 60590 |
| Germany |
| Herzzentrum Leipzig GmbH | Leipzig | Universitätsklinik Für Herzchirurgie Strümpellstraße 39 | 04289 | Germany |
| St.Antonius Hospital | Nieuwegein | Koekoekslaan 1, 3435 CN | Netherlands |
| Radboud universitair medisch centrum | Nijmegen | 6500HB | Netherlands |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000784 | Aortic Dissection |
| D000094626 | Aneurysm, Aortic Arch |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
| D000094665 | Dissection, Blood Vessel |
| D000094683 | Acute Aortic Syndrome |
| D017545 | Aortic Aneurysm, Thoracic |
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