The purpose of this study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications for endovascular peripheral interventions of femoral, popliteal and infrapopliteal lesions.
Subject ≥18 years old
Subject has provided written informed consent
Subject has Rutherford classification 2 to 6
Reference vessel diameter ≥2 and ≤7 mm
Subject has a single target lesion that involves both ATK and BTK segments.
Subject not suitable for receiving endovascular procedures of lower limb arteries.
Prior planned major amputation in the target limb (i.e., above the ankle).
Subject with previous bypass surgery of target vessel.
A total of 200 patients will be enrolled, with approximately 100 subjects in ATK group, and 100 subjects in BTK group.
Cohort
Prospective
Oscar Peripheral Multifunctional Catheter
DeviceOscar Peripheral Multifunctional Catheter encompasses three components: (i) Oscar Support Catheter with integrated Lock Grip, (ii) Oscar Dilator and (iii) Oscar PTA Balloon. Single Oscar PTA Balloon is also available separately and can only be used together with the pre-supplied Oscar Support Catheter as indicated in the compatibility chart in the Instructions for Use (IFU).
Oscar Procedural success rate
combination of Oscar technical success and absence of serious procedural complications
Rate of (Serious) Adverse Device Effects (S)ADE
(Serious) Adverse Device Effects
Rate of distal embolization
Distal embolization
Rate of target vessel rupture
Target vessel rupture
Rate of target vessel perforation
Target vessel perforation
Click on the lead sponsor to view all of their trials.
