The primary objective and hypothesis is to assess whether the SP-GRIPFLOW Catheter is safe and performs as intended. The primary hypothesis is that blood flow through the catheters and cerebral perfusion during open surgical repair of the distal…
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is defined by blood flow through the SP-GRIPFLOW 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
The secondary endpoint of this study will focus on assessment of adequate flow
rate through the SP-GRIPFLOW. Whether the SP-GRIPFLOW 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 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.
The following intraoperative parameters will be assessed as exploratory
endpoints:
• Number of catheter dislocations from target artery
• Near-infrared spectroscopy (O2 saturation)
• Perfusion pressure (mmHg):
o Line pressure
o Pressure at the tip of SP-GRIPFLOW (if available)
o Radial blood pressure, left and right (mmHg)
• Circulatory arrest time (minutes)
• Selective cerebral perfusion time (minutes)
• Perfusion flow rate (mL/kg/min) (maximum and minimum)
• Degree of hypothermia (degrees Celsius) (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])
Background summary
Aortic arch repair often requires a period of systemic circulatory arrest
combined with hypothermia to protect the brain and vital organs. Perfusion
strategies during aortic arch surgery for brain protection include
pharmacologic neuroprotection, hypothermia, or hypothermia in combination with
antegrade cerebral perfusion (ACP), or retrograde cerebral perfusion (RCP).
Perfusion is defined by the passage of blood, a blood substitute, or other
fluid through the blood vessels or other natural channels in an organ or
tissue. ACP has become the standard technique for cerebral perfusion in aortic
repair. The SP-GRIPFLOW Catheter is a silicone catheter equipped with a balloon
to be used during surgery for aortic aneurysm. This product is intended to be
placed in the branches of the aortic arch for the cerebral perfusion during
surgery of aorta. A clinical investigation is required to assess acceptability
of risks associated with clinical use of the device.
Study objective
The primary objective and hypothesis is to assess whether the SP-GRIPFLOW
Catheter is safe and performs as intended. The primary hypothesis is that blood
flow through the catheters and cerebral perfusion during open surgical repair
of the distal aortic arch is confirmed in 95% of cases. This rate was defined
by an estimated rate of catheter obstruction based on clinical judgement by the
investigators (1-5%) and post-market surveillance data collected in Japan (1%).
The safety objective is to assess whether the SP-GRIPFLOW Catheter is
associated with acceptable safety outcomes when compared to the current
knowledge and state of the art.
Study design
This is a pre-market, prospective, single arm, multicenter clinical
investigation.
Intervention
Surgery for aortic arch pathology will be performed in accordance with the
applicable treatment protocol(s) at the investigational site. The clinical
study intervention consists of the use of the investigational device, the
SP-GRIPFLOW Catheter. The SP-GRIPFLOW Catheter will be placed in the target
artery for cerebral perfusion (e.g. left common carotid artery).The
investigator will decide for unilateral (through the brachiocephalic trunk or
left common carotid artery) or bilateral perfusion strategy (combination of
brachiocephalic trunk, left subclavian artery and left common carotid artery).
In addition, the investigator will define a target flow rate for cerebral
perfusion (mL/min/kg).
Study burden and risks
Risks associated with participation in this clinical investigation include
those considered for elective aortic arch repair. These include risks
associated with surgery (infection, hemorrhage, mortality), and more severe
risks of stroke, temporary/permanent neurological dysfunction associated with
malperfusion during surgery. There are no additional risks expected of using
the SP-GRIPFLOW Catheter compared to using a competitor device for antegrade
cerebral perfusion. Use of a balloon catheter may have the following additional
risks compared to a standard cannula:
• Vessel rupture caused by balloon pressure which may result in vessel damage
• Balloon rupture/leak which may result in hemorrhage/air emboli
• Difficult decannulation related to inability to deflate balloon, which may
result in a procedure delay
The following benefits are anticipated for the device:
• The rib on the balloon surface allows for an improved grip and reduction of
dislocation from the target artery.
• A wide catheter inner diameter allows for adequate perfusion flow rates.
Fuji Systems believes that any potential risk presented by this clinical
investigation has been minimized and that adequate testing, safeguards, and
safety monitoring have been incorporated into the clinical investigation to
further minimize and mitigate the risks. Fuji Systems believes that the
benefits of the SP-GRIPFLOW outweigh the potential risks posed to participating
subjects.
This clinical investigation has been designed to involve as little pain,
discomfort, fear and any other foreseeable risks as possible of the subjects.
Hongo 3-Chome 23-14
Bunkyo-ku 113-0033
JP
Hongo 3-Chome 23-14
Bunkyo-ku 113-0033
JP
Listed location countries
Age
Inclusion 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 SP-GRIPFLOW
Catheter (12Fr-16Fr)
Exclusion criteria
• Aortic dissection or rupture which require 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.
• Had cerebral perfusion with another similar device/competitor device in the
last 30 days
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL73323.000.21 |