Peripheral Vascular Disease
Conditions
Keywords
PAD
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 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.
Interventions
DEVICEClotild 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 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.
Sponsors
Sensome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single center, single group, non comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal. | During the procedure, up to 95 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease | During the procedure, up to 95 minutes | 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. |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORKoen Deloose, MD
AZ St Blasius, Dendermonde, Belgium
Participant flow
Recruitment details
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
Baseline characteristics
| Characteristic | — |
|---|---|
| Affected Limb Left | 7 Participants |
| Affected Limb Right | 10 Participants |
| Age, Continuous | 69.0 yrs |
| Ankle Brachial Index | 0.527 mmHg / mmHg |
| BMI | 25.23 kg/m2 |
| Estimated lesion length | 22.1 cm |
| For Acute Onset only: Rutherford Classification (acute onset scale) Category II.a - Marginally Threatened | 3 Participants |
| For Acute Onset only: Rutherford Classification (acute onset scale) Category II.b - Immediately Threatened | 0 Participants |
| For Acute Onset only: Rutherford Classification (acute onset scale) Category III. - Irreversible | 0 Participants |
| For Acute Onset only: Rutherford Classification (acute onset scale) Category I. - Viable | 0 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 0 - Asymptomatic | 0 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 1 - Mild Claudication | 0 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 2 - Moderate Claudication | 2 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 3 - Severe Claudication | 8 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 4 - Ischemic Rest Pain | 4 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 5 - MInor tissue Loss | 0 Participants |
| For Chronic and Subacute onset: Rutherford Classification Category 6 - Major tissue loss | 0 Participants |
| Height | 169.3 cm |
| Lesion Characteristics Concentric | 3 Participants |
| Lesion Characteristics Eccentric | 2 Participants |
| Lesion Characteristics Mixed | 9 Participants |
| Lesion Characteristics Unknown | 3 Participants |
| Lesion Location Other | 4 Participants |
| Lesion Location Superficial Femoral Artery | 10 Participants |
| Lesion Location Superficial Fermoral Artery + Popliteal Artery | 3 Participants |
| Medical History - Number of PAD lesions 0 PAD lesions | 2 Participants |
| Medical History - Number of PAD lesions 1 to 2 PAD lesions | 6 Participants |
| Medical History - Number of PAD lesions 3 to 4 PAD lesions | 6 Participants |
| Medical History - Number of PAD lesions 5 to 9 PAD lesions | 3 Participants |
| Other Medical History Arrhythmia | 1 participants |
| Other Medical History Cardiomyopathy | 3 participants |
| Other Medical History Coronary Artery Disease | 5 participants |
| Other Medical History Diabetes | 6 participants |
| Other Medical History Dyslipidemia | 13 participants |
| Other Medical History Hypertension | 14 participants |
| Other Medical History Other (COPD, .... ) | 9 participants |
| Other Medical History Renal dysfunction | 1 participants |
| Other Medical History Stroke / TIA | 2 participants |
| PAD Onset Acute onset | 3 Participants |
| PAD Onset Chronic onset | 4 Participants |
| PAD Onset Subacute onset | 10 Participants |
| Region of Enrollment Belgium | 17 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 13 Participants |
| Weight | 72.01 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 4 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
None listed