Trial Outcomes & Findings for Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection (NCT NCT06112054)
NCT ID: NCT06112054
Last Updated: 2026-03-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
During the procedure, up to 95 minutes
Results posted on
2026-03-10
Participant Flow
A single center study. The investigator screened and consented patients based upon the eligibility criteria which could take place up to 4 weeks prior to the study procedure. 19 subjects were screened and consented (Intention to Treat Population - ITT). Prior to the study procedure, eligibility was to be reconfirmed. In 2 subjects, eligibility was not confirmed (screen failures). The Treated Population (TP): 17 subjects. First Patient In: 29nov2023 Last Patient Out: 15aug2024
Participant milestones
| Measure |
Single Arm - All Enrolled and Eligible Subjects Were Allocated to the Study Procedure.
19 subjects were screened and gave consent, with 17 subjects being allocated to the study procedure at a single center in Belgium.
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|---|---|
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Overall Study
STARTED
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19
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Overall Study
COMPLETED
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17
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
Single Arm - All Enrolled and Eligible Subjects Were Allocated to the Study Procedure.
19 subjects were screened and gave consent, with 17 subjects being allocated to the study procedure at a single center in Belgium.
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|---|---|
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Overall Study
Did not meet the eligibility criteria just prior to the study procedure
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2
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Baseline Characteristics
19 patients enrolled - 2 screen failures so 17 subjects analysed.
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=17 Participants
One arm only - in all eligible study patients, the study device will be used.
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|---|---|
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Age, Continuous
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69.0 yrs
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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Sex: Female, Male
Female
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4 Participants
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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Sex: Female, Male
Male
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13 Participants
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
|
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Region of Enrollment
Belgium
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17 Participants
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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Height
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169.3 cm
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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Weight
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72.01 kg
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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BMI
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25.23 kg/m2
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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Affected Limb
Left
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7 Participants
n=17 Participants
|
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Affected Limb
Right
|
10 Participants
n=17 Participants
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PAD Onset
Acute onset
|
3 Participants
n=17 Participants
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PAD Onset
Subacute onset
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10 Participants
n=17 Participants
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PAD Onset
Chronic onset
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4 Participants
n=17 Participants
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For Acute Onset only: Rutherford Classification (acute onset scale)
Category I. - Viable
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0 Participants
n=3 Participants • Only patients with acute onset are eligible for this Rutherford Classification, thus 3
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For Acute Onset only: Rutherford Classification (acute onset scale)
Category II.a - Marginally Threatened
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3 Participants
n=3 Participants • Only patients with acute onset are eligible for this Rutherford Classification, thus 3
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For Acute Onset only: Rutherford Classification (acute onset scale)
Category II.b - Immediately Threatened
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0 Participants
n=3 Participants • Only patients with acute onset are eligible for this Rutherford Classification, thus 3
|
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For Acute Onset only: Rutherford Classification (acute onset scale)
Category III. - Irreversible
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0 Participants
n=3 Participants • Only patients with acute onset are eligible for this Rutherford Classification, thus 3
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For Chronic and Subacute onset: Rutherford Classification
Category 0 - Asymptomatic
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0 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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Other Medical History
Renal dysfunction
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1 participants
n=17 Participants
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For Chronic and Subacute onset: Rutherford Classification
Category 1 - Mild Claudication
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0 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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For Chronic and Subacute onset: Rutherford Classification
Category 2 - Moderate Claudication
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2 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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For Chronic and Subacute onset: Rutherford Classification
Category 3 - Severe Claudication
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8 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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For Chronic and Subacute onset: Rutherford Classification
Category 4 - Ischemic Rest Pain
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4 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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For Chronic and Subacute onset: Rutherford Classification
Category 5 - MInor tissue Loss
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0 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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For Chronic and Subacute onset: Rutherford Classification
Category 6 - Major tissue loss
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0 Participants
n=14 Participants • Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14
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Lesion Location
Superficial Femoral Artery
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10 Participants
n=17 Participants
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Lesion Location
Superficial Fermoral Artery + Popliteal Artery
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3 Participants
n=17 Participants
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Lesion Location
Other
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4 Participants
n=17 Participants
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Ankle Brachial Index
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0.527 mmHg / mmHg
n=16 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed. - For one subject, no ABI was examined --\> so 16
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Estimated lesion length
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22.1 cm
n=17 Participants • 19 patients enrolled - 2 screen failures so 17 subjects analysed.
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Medical History - Number of PAD lesions
0 PAD lesions
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2 Participants
n=17 Participants
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Medical History - Number of PAD lesions
1 to 2 PAD lesions
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6 Participants
n=17 Participants
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Medical History - Number of PAD lesions
3 to 4 PAD lesions
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6 Participants
n=17 Participants
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Medical History - Number of PAD lesions
5 to 9 PAD lesions
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3 Participants
n=17 Participants
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Other Medical History
Hypertension
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14 participants
n=17 Participants
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Other Medical History
Dyslipidemia
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13 participants
n=17 Participants
|
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Other Medical History
Diabetes
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6 participants
n=17 Participants
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Other Medical History
Coronary Artery Disease
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5 participants
n=17 Participants
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Other Medical History
Cardiomyopathy
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3 participants
n=17 Participants
|
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Other Medical History
Stroke / TIA
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2 participants
n=17 Participants
|
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Other Medical History
Arrhythmia
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1 participants
n=17 Participants
|
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Other Medical History
Other (COPD, .... )
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9 participants
n=17 Participants
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Lesion Characteristics
Concentric
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3 Participants
n=17 Participants
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Lesion Characteristics
Eccentric
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2 Participants
n=17 Participants
|
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Lesion Characteristics
Mixed
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9 Participants
n=17 Participants
|
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Lesion Characteristics
Unknown
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3 Participants
n=17 Participants
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PRIMARY outcome
Timeframe: During the procedure, up to 95 minutesThe 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.
Outcome measures
| Measure |
Single Arm
n=17 Participants
A total of nineteen subjects were enrolled in the investigation. Two subjects did not confirm the eligibility criteria at the time of the study procedure and were considered screen failure. Therefore seventeen subjects had their procedure in which the study device was used.
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Non-Clot Group
A total of nineteen subjects were enrolled in the investigation. Two subjects did not confirm the eligibility criteria at the time of the study procedure and were considered screen failure. Therefore seventeen subjects had their procedure in which the study device was used. In this population, two categories of cases were identified based on physician's empirical assessment together with each subject's clinical data.
Non-clot group: ninety-six non-anomalous measurements were acquired for which physician assessment and clinical data indicated the absence of a fresh clot.
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|---|---|---|
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The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.
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17 Participants
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—
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SECONDARY outcome
Timeframe: During the procedure, up to 95 minutesPopulation: Non-anomalous measurement acquired by the CSGS during the procedure - for each measurements, the investigator had to assess if the CSGS was in contact with a fresh-clot or other.
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.
Outcome measures
| Measure |
Single Arm
n=26 Non-anomalous measurement
A total of nineteen subjects were enrolled in the investigation. Two subjects did not confirm the eligibility criteria at the time of the study procedure and were considered screen failure. Therefore seventeen subjects had their procedure in which the study device was used.
|
Non-Clot Group
n=96 Non-anomalous measurement
A total of nineteen subjects were enrolled in the investigation. Two subjects did not confirm the eligibility criteria at the time of the study procedure and were considered screen failure. Therefore seventeen subjects had their procedure in which the study device was used. In this population, two categories of cases were identified based on physician's empirical assessment together with each subject's clinical data.
Non-clot group: ninety-six non-anomalous measurements were acquired for which physician assessment and clinical data indicated the absence of a fresh clot.
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|---|---|---|
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The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease
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0.3782 probability to be a fresh-clot
Standard Deviation 0.4690
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0.0284 probability to be a fresh-clot
Standard Deviation 0.1430
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Adverse Events
Single Arm - All Enrolled and Eligible Subjects Were Allocated to the Study Procedure.
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm - All Enrolled and Eligible Subjects Were Allocated to the Study Procedure.
n=17 participants at risk
19 subjects were screened and gave consent, with 17 subjects being allocated to the study procedure at a single center in Belgium (Treated Population). As per protocol, Adverse Events were only collected in the Treated Population.
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|---|---|
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Blood and lymphatic system disorders
Femoral Artery Dissection
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17.6%
3/17 • Number of events 3 • As per protocol, Adverse Events were only collected in the Treated Population, meaning as from the moment the eligibility was confirmed during the peripheral artery disease procedure and immediately prior to the study procedure, up to the follow-up visit at 24 hours (-12 hours) post procedure.
The investigator assessed the causality of all AEs in relation to the research, i.e., the relationship between the AE / SAE and: * The investigational device, * The investigational procedure, * The peripheral artery disease procedure
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Blood and lymphatic system disorders
Arterial Hemorrhage
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5.9%
1/17 • Number of events 1 • As per protocol, Adverse Events were only collected in the Treated Population, meaning as from the moment the eligibility was confirmed during the peripheral artery disease procedure and immediately prior to the study procedure, up to the follow-up visit at 24 hours (-12 hours) post procedure.
The investigator assessed the causality of all AEs in relation to the research, i.e., the relationship between the AE / SAE and: * The investigational device, * The investigational procedure, * The peripheral artery disease procedure
|
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Blood and lymphatic system disorders
Remaining thrombus after thrombolysis
|
5.9%
1/17 • Number of events 1 • As per protocol, Adverse Events were only collected in the Treated Population, meaning as from the moment the eligibility was confirmed during the peripheral artery disease procedure and immediately prior to the study procedure, up to the follow-up visit at 24 hours (-12 hours) post procedure.
The investigator assessed the causality of all AEs in relation to the research, i.e., the relationship between the AE / SAE and: * The investigational device, * The investigational procedure, * The peripheral artery disease procedure
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Blood and lymphatic system disorders
Femoral Artery Perforation
|
5.9%
1/17 • Number of events 1 • As per protocol, Adverse Events were only collected in the Treated Population, meaning as from the moment the eligibility was confirmed during the peripheral artery disease procedure and immediately prior to the study procedure, up to the follow-up visit at 24 hours (-12 hours) post procedure.
The investigator assessed the causality of all AEs in relation to the research, i.e., the relationship between the AE / SAE and: * The investigational device, * The investigational procedure, * The peripheral artery disease procedure
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place