No registrations found.
ID
Source
Brief title
Health condition
abdominal aortic aneurysm (AAA), iliac aneurysms (IA), stenotic lesions of the iliac artery or Superficial Femoral Artery (SFA).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Technical success of navigation
Secondary outcome
-Procedural technical success (defined as successful completion of the procedure)
-Type of procedure
-Cumulative Air Kerma (AK)
-Cumulative Dose Air Product (DAP)
-Cumulative Digital Subtraction Angiography (DSA) dose
-Cumulative fluoroscopy dose
-Cumulative fluoroscopy time
-Cumulative contrast agent volume
-Cumulative staff dose for each staff member (operator 1, operator 2, sterile nurse)
-Radiation dose XperCT, if applicable
-“Skin-to-skin” procedure time
-Time to perform each navigation task
-AK of each navigation task
-DAP of each navigation task
-Fluoroscopy time of each navigation task
-Staff dose of each staff member for each navigation task (operator 1, operator 2, sterile nurse)
-Number of re-registrations of CTA
-Number of re-registrations of FORS-enabled device visualization
-Number of bail outs (switch to X ray-guidance only) during navigation tasks and reason for it
-Type of treatment device (type, brand)
-Serious Adverse Device Effects (SADEs)
Background summary
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 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 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 (FIH) trial to evaluate the use of such a device.
Study objective
The objective of this study is to assess performance of navigation in the arterial tree by using Fiber Optic RealShape (FORS)-enabled catheters and guidewires, thereby using FORS-based guidance as add-on to X ray imaging, in aortic and peripheral endovascular procedures. Performance, therefore, concerns two aspects: 1) performance of the FORS-enabled devices, and 2) performance of the FORS-based image guidance, as add on to X ray. Hence, performance of the Philips AltaTrack investigational device will be assessed through: 1) technical success of navigation in the arterial tree by using the FORS-enabled catheters and guidewires, and 2) qualitative judgement by the operator on the usefulness of FORS-based image guidance.
Study design
not applicable
Intervention
-aortic endovascular intervention
-peripheral endovascular intervention
J.A. Herwaarden, van
Postbus 85500
Utrecht 3508 GA
The Netherlands
0887556965
j.a.vanherwaarden@umcutrecht.nl
J.A. Herwaarden, van
Postbus 85500
Utrecht 3508 GA
The Netherlands
0887556965
j.a.vanherwaarden@umcutrecht.nl
Inclusion criteria
-Age > 18 years
-Willingness to sign the informed consent
-Scheduled for elective endovascular procedure either for stenotic or aneurysmatic pathology
-Anatomical conformation suitable for the investigational medical devices (5.5 F 80cm Cobra C2 catheter, and/or 5.5F 80cm Berenstein catheter, and a 0.035” 120cm floppy guidewire)
Exclusion criteria
-Intolerance to contrast media
-Emergency procedure
-Current participation in a concurrent trial that may confound study results
-Subjects unwilling or unable to comply with the protocol
-Subjects unable to understand verbal and/or written informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7074 |
| NTR-old | NTR7272 |
| CCMO | NL65894.041.18 |
| OMON | NL-OMON46231 |