Aneurysm and reduced blood flow
Conditions
Interventions
Lumiguide, a Philips visualization device to visualize angiographic catheters and guidewires for navigation and posittiong in 3D realtime.
Sponsors
Philips
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair. Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law. Subject has a life expectancy of at least 2 years Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries
Exclusion criteria
Exclusion criteria: Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair Subject treated for re-intervention / staged procedure post-primary FEVAR procedure Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate) Subject treated for an emergent (<24hrs after emergence) procedure Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome Subject with contrast allergies Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips. All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any. Subject unwilling or unable to comply with the protocol unable to understand verbal and/or written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure Fluoroscopy time (min) To demonstrate whether LumiGuide reduces fluoroscopy time on the whole procedure. As conventional methods require continuous fluoroscopy exposure to visualize the guidewire and catheter during navigation, fluoroscopy time most accurately reflects the impact of LumiGuide versus fluoroscopy guidance. Therefore procedure fluoroscopy time was chosen as primary endpoint for the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fluoroscopy time (min) during task navigation The current generation of Compatible Wires can be used only during the navigation phase of a catheterization task because it is not backloadable. As conventional methods require continuous fluoroscopy exposure to visualize the guidewire and catheter during navigation, fluoroscopy time most accurately reflects the impact of FORS versus fluoroscopy guidance. Fluoroscopy rate (%) during task navigation Fluoroscopy rate during task navigation is fluoroscopy time normalized over the time it took to complete the task. This derived parameter accounts for variability in the task duration that adds variability to the fluoroscopy data that is unrelated to LumiGuide. Dose Area Product (DAP, Gy*cm2) during task navigation DAP is an output parameter that reflects the total amount of radiation delivered to the patient. Because of the clinical relevance it is included as a secondary endpoint in the study design. There are a number of factors (e.g. x-ray system configuration, patient demographics etc.) that contribute to the total dose delivered to the patient that cannot be controlled for, which is why it is not selected as primary endpoint. Air Kerma (AK, mGy) during task navigation Air Kerma is an output parameter that reflects the dose the patient*s skin receives. Because of the clinical relevance it is included as a secondary endpoint in the study design. There are a number of factors (e.g. x-ray system configuration, C-arc angle etc.) that contribute to the total dose delivered to the patient that cannot be controlled for, which is why it is not selected as primary endpoint. Procedure fluoroscopy dose (Gy*cm2) To assess whether there as a cumulative effect of LumiGuide on fluoroscopy dose on the whole procedure. Procedure Dose Area Product (DAP, Gy*cm2) To assess whether there as a cumulative effect of LumiGuide on DAP on the whole procedure. Procedure Air Kerma (AK, mGy) To assess whether there as a cumulative effect of Lum | — |
Countries
Netherlands
Contacts
Public ContactB Wessels
Philips
Outcome results
None listed