Peripheral Arterial Disease Below The Knee
Conditions
Brief summary
The rationale of this study is to confirm and support the clinical safety and performance of the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Catheters, the Luminor 14m and Luminor 18 Drug Coated Balloons, the Angiolite BTK Sirolimus Eluting Peripheral Stent System and the Sergeant Peripheral Support Catheter in a real-word population of 143 patients who underwent an endovascular intervention the popliteal and/or infrapopliteal arteries within standard-of-care (SOC) where at least 1 of the investigational products from iVascular were used.
Interventions
None listed
Sponsors
FCRE (Foundation for Cardiovascular Research and Education)
iVascular S.L.U.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device. 2. Patient is \>18 years old. 3. Patient understands the nature of the procedure and provides written informed consent prior to enrolment in the study. 4. Target lesion(s) is/are located in the popliteal or infrapopliteal arteries 5. Patient is eligible for treatment with the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter as described in the IFU for each device.
Exclusion criteria
1. Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices. 2. Known contraindication and/or allergy to (a component of) an investigational device. 3. Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding. 4. Life expectancy of less than 12 months. 5. Any planned surgical intervention/procedure within 30 days after the study procedure. 6. Any patient considered to be hemodynamically unstable at onset of procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: Freedom from SAE/SADE | 2 years | Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effects (SADEs) during the procedure and up to 2 years after the procedure (depending on the device that was used). |
| Primary Efficacy Endpoint: Technical success | During procedure | Technical success rate defined as successful crossing, introduction and deployment of the Oceanus 14pro Balloon Catheter and/or the Oceanus 18 Balloon Catheter and/or the Oceanus 35 Balloon Catheter and/or the Luminor 14m DCB and/or the Luminor 18 DCB and/or the Angiolite BTK Sirolimus Eluting Peripheral Stent System and/or the Sergeant Peripheral Support Catheter according to the respective IFU and without device related deficiencies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician Appraisal | During procedure | General physician appraisal of the devices will be explored based on 1. Simplicity of handling 2. Pushability 3. Trackability 4. Crossability 5. Profile Physician appraisal of the Luminor 14m and Luminor 18 Drug Coated Balloon Dilatation Catheters and the Oceanus 14pro, Oceanus 18 and Oceanus 35 Balloon Dilatation Catheters will be explored based on 1\. Deflation time 2. Balloon Compliance 3. Visibility 4. Balloon refolding Physician appraisal for the Angiolite BTK Sirolimus Eluting Peripheral Stent System will be explored based on 1. Recoil 2. Radial force 3. Ease to canalize the lesion 4. Stent coverage 5. Stent graft recrossing 6. Balloon refusal And physician appraisal for the Sergeant Peripheral Support Catheter will be explored based on 1\. Trackability over the guide wire 2. Absence of kinking behaviour 3. Injection Capacity 4. Ease of changing guide wires 5. Ease to canalize the lesion |
| Freedom from SAE | 2 years | Freedom from SAE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used) |
| Freedom from SADE | 2 years | Freedom from SADE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used) |
| Freedom from TLR | 2 years | Freedom from Target Lesion Revascularization post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used), defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge. |
Countries
Belgium
Contacts
Primary ContactMieke Ramsdonck
Outcome results
None listed