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The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | One arm only - in all eligible study patients, the study device will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koen Deloose, MD | AZ St Blasius, Dendermonde, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint Blasius | Dendermonde | 9200 | Belgium |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Two subjects consented and had the screening/basline visit - however, immediately prior to the study procedure, the eligibility criteria could not be confirmed. These two subjects does became screen failures
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | One arm only - in all eligible study patients, the study device will be used. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is recorded for each patient |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | During the procedure, up to 95 minutes |
|
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:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 (Treated Population). As per protocol, Adverse Events were only collected in the Treated Population. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral Artery Dissection | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | all assessed as mild with a causal relationship to the PAD procedure, no relation to the study device or study procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Lafaurie | SENSOME | +33 1 85 37 07 70 | julie@sensome.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2023 | Feb 16, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2024 | Feb 16, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Single center, single group, non comparative study
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|
| During the procedure, up to 95 minutes |
19 patients enrolled - 2 screen failures so 17 subjects analysed.
| Mean |
| Full Range |
| yrs |
|
| Sex: Female, Male | 19 patients enrolled - 2 screen failures so 17 subjects analysed. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 19 patients enrolled - 2 screen failures so 17 subjects analysed. | Count of Participants | Participants | No |
|
| Height | Height is measured in each patient | 19 patients enrolled - 2 screen failures so 17 subjects analysed. | Mean | Full Range | cm |
|
| Weight | Weight is measured for each patient | 19 patients enrolled - 2 screen failures so 17 subjects analysed. | Mean | Full Range | kg |
|
| BMI | Body Mass Index | 19 patients enrolled - 2 screen failures so 17 subjects analysed. | Mean | Full Range | kg/m2 |
|
| Affected Limb | The limb (left or right) in which the Peripheral Artery Disease procedure (and thus also the study procedure) took place. | Count of Participants | Participants |
|
| PAD Onset | PAD = Peripheral Artery Disease Acute onset (sudden appearance of pain in the last 14 days) Subacute onset: appearance of pain less than 3 months but more than 2 weeks Chronic onset: chronic pain for more than 3 months | Count of Participants | Participants |
|
| For Acute Onset only: Rutherford Classification (acute onset scale) | Rutherford Acute Onset classification: Category I. - Viable - Not immediately threatened Category II.a - Marginally Threatened - Salvageable if promptly treated Category II.b - Immediately Threatened - Salvageable with immediate revascularization Category III. - Irreversible - Major tissue loss or permanent nerve damage inevitable | Only patients with acute onset are eligible for this Rutherford Classification, thus 3 | Count of Participants | Participants |
|
| For Chronic and Subacute onset: Rutherford Classification | Category 0 - Asymptomatic - no hemodynamically significant occlusive disease Category 1 - Mild claudication Category 2 - Moderate claudication Category 3 - Severe claudication Category 4 - Ischemic rest pain Category 5 - Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal ischemia Category 6 - Major tissue loss - extending above Transmetatarsal level, functional foot no longer salvageable | Only patients with subacute and chronic onset are eligible for this Rutherford Classification, thus 14 | Count of Participants | Participants | No |
|
| Lesion Location | Lesions had to be located at the arteries of the lower limbs, eligible for endovascular interventional procedures, lesions starting at the common iliac artery excluded. | Count of Participants | Participants |
|
| Ankle Brachial Index | The ankle-brachial index (ABI) is a quick, non-invasive test used to assess blood flow in the legs and detect peripheral artery disease (PAD). It compares blood pressure in the ankle to blood pressure in the arm. A low ABI suggests narrowed arteries in the legs, potentially indicating PAD | 19 patients enrolled - 2 screen failures so 17 subjects analysed. - For one subject, no ABI was examined --> so 16 | Mean | Full Range | mmHg / mmHg |
|
| Estimated lesion length | 19 patients enrolled - 2 screen failures so 17 subjects analysed. | Mean | Full Range | cm |
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| Medical History - Number of PAD lesions | Subjects with previous PAD lesions | Count of Participants | Participants |
|
| Other Medical History | Number | participants |
|
| Lesion Characteristics | In peripheral artery disease (PAD), concentric lesions involve uniform plaque buildup around the entire arterial circumference, eccentric lesions show plaque localized to one side of the artery with a disease-free wall segment, and mixed lesions combine features of both, with asymmetrical but partially circumferential plaque distribution | Count of Participants | Participants |
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| 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:
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. | 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. | Posted | Mean | Standard Deviation | probability to be a fresh-clot | During the procedure, up to 95 minutes | Non-anomalous measurement | Non-anomalous measurement |
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|
| 0 |
| 17 |
| 0 |
| 17 |
| 4 |
| 17 |
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| Arterial Hemorrhage | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | assessed as mild, probably related to the PAD procedure, no relation to the study device or study procedure |
|
| Remaining thrombus after thrombolysis | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | assessed as moderate, probably related to the PAD procedure, no relation to the study device or study procedure |
|
| Femoral Artery Perforation | Blood and lymphatic system disorders | MEDRA | Systematic Assessment | assessed as moderate, causal relationship to the PAD procedure, no relation to the study device or study procedure |
|
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