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Completed

NCT Number: NCT06112054

Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

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

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Key information

Conditions

Peripheral Vascular Disease Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Sint Blasius

Dendermonde, 9200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clotild Smart Guidewire System (CSGS)

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 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.

Primary outcomes

  1. The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.

    Time frame: During the procedure, up to 95 minutes

    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.

Secondary outcomes

  1. The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease

    Time frame: During the procedure, up to 95 minutes

    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.

Sponsors and collaborators

Lead sponsor

Sensome

Industry

Registry information

Acronym: SEPARATE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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