A Prospective PMCF Study Investigating the Safety and Clinical 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 for the Endovascular Intervention in Popliteal and Infrapopliteal Arteries
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.
• Corresponding to the CE-mark indications/contra-indications and according to the IFU of the device.
• Patient is \>18 years old.
• Patient understands the nature of the procedure and provides written informed consent prior to enrolment in the study.
• Target lesion(s) is/are located in the popliteal or infrapopliteal arteries
• 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.