N/A
N=19
Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT06112054 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal. — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Clotild Smart Guidewire System (CSGS) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sensome
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal. |
17 | — |
| SECONDARY The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease |
0.3782; 0.0284 | <=0.0001 sig |
Summary
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06112054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.