Overview
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).
Description
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD)
Previously the CSGS was used in a clinical study in stroke patients (The Clot Out Study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures.
In the current study however, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire System will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedures.
Eligibility
Inclusion Criteria:
- Age > 18 years
- Subjects with acute and chronic occlusions in the arteries of the lower limbs
- Patients eligible for endovascular interventional procedures
- Written Informed Consent to participate in the study.
Exclusion Criteria:
- Target Vessel Aneurysm
- Target vessel diameter <2mm
- Lesions starting at the Common Iliac Artery
- Any subject that is, according to the discretion of the investigator, not eligible for study participation
- Known lactating or confirmation of positive pregnancy test according to site specific standard of care