Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

NCT ID: NCT06112054

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-17
• Study Completion Date: 2024-08-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment Arm

One arm only - in all eligible study patients, the study device will be used.

Group Type: EXPERIMENTAL

Clotild Smart Guidewire System (CSGS)

Intervention Type: DEVICE

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 sensors) in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedure

Interventions

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 sensors) in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedure

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AZ Sint Blasius

Dendermonde, , Belgium

Countries

Belgium

Other Identifiers

SEN-PAD-1

Identifier Type: -

Identifier Source: org_study_id