The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
The main question[s] it aims to answer are:
* Is the Thor system safe in treating these lesions
* Does the Thor system work to treat these lesions
Participants will:
* Receive treatment with the Thor system
* Have follow-up visits at Discharge, 30 days, 6 months, and 12 months
MA_MCS_Alar SpO2 Sensor Pilot study_2020_11181
BACKGROUND: As the normal functioning of the body is dependent on oxygen, low blood oxygenation is a acute problem that needs immediate attention. Measurement of blood oxygenation is therefore central to monitor patients and is usually done using light technology with a clip on the finger. Philips manufactures a measuring clip that is designed to measure oxygenation in the nasal wing instead of the finger. The advantage of this is that the nose is not affected as much as the fingers by poor blood flow in the skin, for example caused by cold. The nose is also closer to the heart and lungs than the hand, so changes in oxygenation may be detected earlier. This newer meter is an approved CE-marked product that is available for clinical use, but the next step is to investigate it systematically during and after surgery.
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
Primary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)
100 Clinical Results associated with Philips Clinical & Medical Affairs Global.
0 Patents (Medical) associated with Philips Clinical & Medical Affairs Global.
100 Deals associated with Philips Clinical & Medical Affairs Global.
100 Translational Medicine associated with Philips Clinical & Medical Affairs Global.