Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

NCT06112054 | Completed Results DMC

• 1 other identifier: SEN-PAD-1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Vascular Disease

Keywords

PAD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  During the procedure, up to 95 minutes

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Device: Clotild Smart Guidewire System (CSGS)

Interventions

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.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensome: lead

Study Sites (1)

AZ Sint Blasius

Dendermonde, 9200, Belgium

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Julie Lafaurie
• Organization: SENSOME

julie@sensome.com

+33 1 85 37 07 70

Study Officials

• Koen Deloose, MD

  AZ St Blasius, Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center, single group, non comparative study

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: November 1, 2023
• Study Start: November 29, 2023
• Primary Completion: August 14, 2024
• Study Completion: August 15, 2024
• Last Updated: March 10, 2026
• Results First Posted: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)