I70.2
Conditions
Interventions
Group 1: Carrying out endovascular procedures on the iliac and leg arteries with the assistence of the navigation assistance Vascular Navigation PAD
Group 2: Carrying out endovascular procedures on th
Sponsors
Brainlab
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Subject has been diagnosed with peripheral arterial disease of the lower limbs or iliac arteries, all clinical stages • Subject is eligible for endovascular surgery • Subject provides written informed consent
Exclusion criteria
Exclusion criteria: • Subject requires bypass surgery or other conventional surgery revascularization • Subject has a known contrast agent allergy • Subject is pregnant or nursing • Subject is unable to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the devices ability to reduce contrast agent compared to procedures without the device. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Determination of the devices ability to reduce radiation dose to the patient compared to procedures without the device • Determination of the device’s ability to reduce radiation dose to the physician compared to procedures without the device • Determination of the devices ability to reduce Air-Kerma to the patient compared to procedures without the device • Qualitative assessment of the devices ability to enable navigation of endovascular devices to defined targets in PAD procedures | — |
Countries
Germany
Contacts
Public ContactAlexander Hyhlik-Dürr
Uniklinikum Augsburg
Outcome results
None listed