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| Name | Class |
|---|---|
| FCRE (Foundation for Cardiovascular Research and Education) | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint: Freedom from SAE/SADE | 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). | 2 years |
| Primary Efficacy Endpoint: Technical success | 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. | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Appraisal | General physician appraisal of the devices 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. 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 |
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Inclusion Criteria:
Exclusion Criteria:
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In this PMCF minimally invasive medical devices with special dedication towards the interventional cardiovascular field will be used. Indications for which the investigational devices are intended are listed in the protocol. Patients will be selected based on the investigator's assessment and evaluation of the underlying disease. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required assessment or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available follow-up.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mieke Ramsdonck | Contact | mieke.ramsdonck@FCRE.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Bonheiden | Recruiting | Bonheiden | Belgium |
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| During procedure |
| Freedom from SAE | Freedom from SAE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used) | 2 years |
| Freedom from SADE | Freedom from SADE post-procedure and after 30 days, 1 year and 2 years (depending on the device that was used) | 2 years |
| Freedom from TLR | 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. | 2 years |
| Jessa Hasselt | Recruiting | Hasselt | Belgium |
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| Az Groeninge Kortrijk | Recruiting | Kortrijk | Belgium |
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| Az Sint Maarten Mechelen | Recruiting | Mechelen | Belgium |
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| HH Mol | Recruiting | Mol | Belgium |
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| Az Damiaan Oostende | Recruiting | Ostend | Belgium |
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| RZ Tienen | Recruiting | Tienen | Belgium |
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| Az Jan Portaels Vilvoorde | Recruiting | Vilvoorde | Belgium |
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