First-in-Human for Fiber Optic RealShape (FORS)

In the past years, the endovascular approach has become the standard treatment
option for an increasing portion of patients affected by aortic and/or iliac
aneurysms, as well as for patients with peripheral occlusive disease in lower
limbs. The gold standard imaging modality for peripheral endovascular
procedures is X ray imaging. The availability of new and improved treatment
devices, which can treat increasingly difficult anatomies, has also resulted in
increasingly complex procedures, with long procedural times, high radiation
exposure and large contrast agent volume. This calls for development of new
tools to make complex procedures faster, easier to perform, and feasible with
less radiation exposure and lower contrast dose. Philips has developed the
AltaTrack device, which provides a more intuitive visualization of both the
anatomy and of the in-patient devices. The 3D real time visualization of the
in-body instruments is obtained by employing the light-based Fiber Optic
RealShape (FORS) technology. The FORS-enabled catheters and guidewires are
entirely equivalent in mechanical behaviour and radiopacity to standard
angiographic catheters and guidewires; in addition, they provide an X ray-free
3D visualization of the medical instrument in the patient*s body. The use of
this technology for guidance in navigation during peripheral endovascular
procedures can potentially lead to reduced radiation exposure, for patients and
staff, reduced contrast dose and shorter procedure times. The AltaTrack device
is a non-CE marked device and has never been tested in human subjects. This
Study is the first-in-human trial to evaluate the use of such a device.

The objective of this study is to assess performance of navigation in the
arterial tree by using catheters and guidewires that are enabled with
FORS-based guidance as add-on to X ray imaging, in aortic and peripheral
endovascular procedures.

This is a single center, open label, single arm, and prospective interventional
trial, in subjects that undergo elective aortic or peripheral endovascular
treatment. The study will include up to 20 subjects.

All study subjects will undergo patient care as in the current practice, pre-as
well as post-treatment. During the treatment intervention, all steps of the
intervention will be executed as in current practice except for the navigation
part. During navigation to reach the area to treat, instead of using catheters
and guidewires, which only rely on X ray for visualization, the FORS-enabled
catheters and guidewires will be used, thereby providing FORS-based image
guidance in addition to X ray.

In this study, the risk and burden to the subjects have been judged by several
physicians to be minimal. The subjects involved will be scheduled for standard
endovascular treatment and the use of the investigational device does not
represent higher risk or burden compared to the use of devices commercially
available and employed in the standard of practice.
On the other hand, the investigational device provides more intuitive
information to the operator on the in-body location of the device during the
intervention, thereby, potentially making the navigation step of the
intervention easier to perform. As a result, procedure times may become
shorter. In addition, the use of the investigational device may lead to a
reduction of radiation exposure to the patient (and to the operator), and a
reduction of contrast agent volume. Therefore, the outcome of this study may be
potentially beneficial for all patients that will be scheduled for endovascular
treatment in the future.