Subject indicated for primary endovascular repair procedures in the peripheral, aortic and aortic side branch vasculature Circulatory System
Conditions
Interventions
There are no study-related procedures for this study other than collecting patient and procedure-related data on top of normal clinical practice. Data that will be collected includes, but is not limit
Sponsors
Philips Medical Systems Nederland B.V.
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject indicated for any of the following primary endovascular repair procedures in the peripheral, aortic and aortic side branch vasculature including, 1.1. Complex EVAR (B/FEVAR and PMEG) 1.2. Standard EVAR, including IBD 1.3. Lower extremity PTA & stenting 1.4. Lower extremity venous obstruction repair 2. Subject can give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law
Exclusion criteria
Exclusion criteria: 1. Subject participates in a potentially confounding drug or device trial during the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips 2. Subject treated for re-intervention (e.g. endoleak, rebleeding) or staged procedure post-primary repair procedure 3. Subjects indicated for endovascular repair procedure not listed in the inclusion criteria (e.g. TEVAR, Chimney/snorkel, CERAB) unless pre-approval is obtained from Philips 4. All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, subjects in emergencies, pregnant or breastfeeding women, or any other subject who meets exclusion criteria, according to applicable national laws, if any 5. Subject unwilling or unable to comply with the protocol and unable to understand verbal and/or written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Procedure time, defined as duration (min), measured using data collected in procedure records at one timepoint 2. Radiation exposure, defined as fluoroscopy time (min) and dose (Gy*cm2), digital subtraction angiography dose (DSA) (DAP, Gy*cm2), dose area product dose (DAP, Gy*cm2), air kerma (AK, mGy) and contrast agent volume (mL), measured using data collected in procedure records at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Austria, Belgium, Denmark, England, France, Germany, Netherlands, Sweden, United Kingdom, United States of America
Contacts
Public ContactBart Wessels
Outcome results
None listed