Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

Peripheral Vascular Disease Clinical Trial

— SEPARATE  

Official title:

Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06112054
• Other study ID #: SEN-PAD-1
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Sensome
• Contact: Julie Lafaurie
• Phone: +33 1 85 37 07 70
• Email: Julie[@]sensome.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Sint Blasius	Dendermonde

Sponsors (1)

Lead Sponsor	Collaborator
Sensome

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability of Clotild® Smart Guidewire System 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. Data of the 9 individual impedance measurements will be collected during the procedure and might be aggregated at the row level or sensor level. This endpoint represents the procedural success rate being defined as the CSGS obtaining at least one non-anomalous impedance measurement in the lesion during the procedure.	During the procedure
Secondary	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; The ability to differentiate tissues will be reported by descriptive statistics.; To further assess the secondary endpoint, Machine Learning analysis will be applied. Following standard procedure, features will be extracted from the impedance measurements and used for model inference.	During the procedure