Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection (SEPARATE)

Sensome

Status

Completed

Conditions

Peripheral Vascular Disease

Treatments

Device: Clotild Smart Guidewire System (CSGS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT06112054

SEN-PAD-1

Details and patient eligibility

About

The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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