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

Primary Purpose

Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Selective Cerebral Perfusion Catheter
Sponsored by
Fuji Systems Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum Freiburg
  • Universitätsklinikum Frankfurt
  • Herzzentrum Leipzig GmbH
  • St.Antonius Hospital
  • Radboud universitair medisch centrum

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SP-GRIPFLOW

Arm Description

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.

Outcomes

Primary Outcome Measures

"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

Secondary Outcome Measures

"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.

Full Information

First Posted
April 22, 2022
Last Updated
July 9, 2023
Sponsor
Fuji Systems Corporation
Collaborators
Avania
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1. Study Identification

Unique Protocol Identification Number
NCT05421130
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuji Systems Corporation
Collaborators
Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm, Aortic Arch; Aneurysm, Dissecting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
149 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SP-GRIPFLOW
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Selective Cerebral Perfusion Catheter
Other Intervention Name(s)
SP-GRIPFLOW
Intervention Description
This product is intended to be placed in the branches of the aortic arch for the cerebral perfusion during surgery of aorta.
Primary Outcome Measure Information:
Title
"Successful perfusion" defined by flow rate through the catheter (mL/kg/min)
Description
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
Time Frame
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 Outcome Measure Information:
Title
"Adequate flow rate" assessed by a clinically relevant through the catheter(mean and maximum flow rate「mL/kg/min」). endpoints
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
The nature, severity and incidence of adverse events at 30-days post-procedure
Description
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.
Time Frame
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.
Title
The collection of an intraoperative parameters(Number of catheter dislocations from target artery (Units))
Description
Number(Units) of catheter dislocations from target artery will be assessed as exploratory endpoints.
Time Frame
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.
Title
The collection of an intraoperative parameters(Near-infrared spectroscopy (O2 saturation))
Description
Near-infrared spectroscopy (O2 saturation) will be assessed as exploratory endpoints.
Time Frame
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.
Title
The collection of an intraoperative parameters (Perfusion pressure (mmHg))
Description
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
Time Frame
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.
Title
The collection of an intraoperative parameters (Circulatory arrest time (minutes))
Description
Circulatory arrest time(minutes) will be assessed as exploratory endpoints.
Time Frame
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.
Title
The collection of an intraoperative parameters (Selective cerebral perfusion time (minutes))
Description
Selective cerebral perfusion time (minutes) will be assessed as exploratory endpoints.
Time Frame
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.
Title
The collection of an intraoperative parameters(Perfusion flow rate (mL/kg/min) (maximum and minimum))
Description
Perfusion flow rate (mL/kg/min) (maximum and minimum) will be assessed as exploratory endpoints.
Time Frame
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.
Title
The collection of an intraoperative parameters(Degree of hypothermia (degrees Celsius))
Description
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])
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
State/Province
Campus Freiburg: Hugstetter Straße 55
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
State/Province
Theodor-Stern-Kai 7,
ZIP/Postal Code
60590
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
State/Province
Universitätsklinik Für Herzchirurgie Strümpellstraße 39
ZIP/Postal Code
04289
Country
Germany
Facility Name
St.Antonius Hospital
City
Nieuwegein
State/Province
Koekoekslaan 1, 3435 CN
Country
Netherlands
Facility Name
Radboud universitair medisch centrum
City
Nijmegen
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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