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

Completed

Conditions: bloedvataandoeningen van aorta en lager> arteriosclerose, stenose, vaatinsufficiëntie en necrose
Aneurysm
Peripheral Artery Disease
10002363

Registration Number: NL-OMON46231

Lead Sponsor: Philips

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

• Age > 18 years.
• Willingness to sign 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study endpoint is the technical success of well-defined navigation tasks<br /><br>during the endovascular procedure. Also, qualitative scores will be collected<br /><br>from the operator on performance parameters of FORS-enabled image guidance as<br /><br>add-on to X ray. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additional study endpoints are: procedural technical success, ski-to-skin<br /><br>procedure time, cumulative radiation dose (for patient, for each staff member),<br /><br>cumulative fluoroscopy time, navigation task time, navigation radiation dose<br /><br>(for patient, for each staff member), navigation fluoroscopy time, cumulative<br /><br>contrast agent dosevolume. </p><br>