NCT06112054

Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sensome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Clotild Smart Guidewire System (CSGS)	In the current study, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire (study device) will only be used to perform electrophysiological measurements (via its sensor) in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedure. During the procedure, the physician acquired measurements at several locations within the lesion to target the various tissues of interest. The physician labeled the data according to tissue type, relying on the patient's symptoms and other available clinical information.

Timeline

• Start date: 2023-11-29
• Primary completion: 2024-08-14
• Completion: 2024-08-15
• First posted: 2023-11-01
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

1 site across 1 country: Belgium