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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Clotild Smart Guidewire System (CSGS)

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Dendermonde, Belgium, 9200
    • AZ Sint Blasius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment Arm; One arm only - in all eligible study patients, the study device will be used.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.	The Primary Performance Endpoint is defined as the ability of Clotild® Smart Guidewire System to acquire electrophysiological measurements in the lesion and/or subintimal. This endpoint represents the procedural success rate being defined as the number of patients in whom the CSGS ( Clotild® Smart Guidewire System) obtained at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom CSGS was used.	During the procedure, up to 95 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease	The ability of Clotild® Smart Guidewire System to differentiate various tissues involved in Peripheral Artery Disease such as, but not limited to: arterial wall; subintimal area; clot (fresh / subacute / organised); plaque (soft / hard); hyperplasia Due to limitations in data and label collection, the secondary endpoint could only be assessed by the development of a model performing binary classification distinguishing fresh-clot from every other tissue type. The non-anomalous impedance measurement are interpreted by a prediction model. This model provides a calibrated probability that a given non-anomalous measurement corresponds to a fresh clot. To assess alignement with the physician assessment, the model probabilities were compared with the physician assigned labels (fresh clot vs non fresh clot). For each physician's assigned group, the mean calibrated probabilities and its standard deviation are reported.	During the procedure, up to 95 minutes

Collaborators and Investigators

• Sponsor: Sensome
• Investigators: Principal Investigator: Koen Deloose, MD, AZ St Blasius, Dendermonde, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Actual): August 14, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: PAD
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases
• Other Study ID Numbers: SEN-PAD-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No