Status:

COMPLETED

Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection

Lead Sponsor:

Sensome

Conditions:

Peripheral Vascular Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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 s...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 15 2024

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT06112054

Start Date

October 17 2023

End Date

August 15 2024

Last Update

January 10 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

AZ Sint Blasius

Dendermonde, Belgium, 9200