The goal of this clinical trial is to learn if using the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon for vessel preparation improves outcomes before drug-coated balloon (DCB) treatment in patients with femoropopliteal artery narrowing or blockage. It will also learn about the safety of the Chocolate PTA balloon. The main questions it aims to answer are:
Does using the Chocolate PTA balloon reduce the need for bailout stenting or vessel complications during DCB treatment?
What medical problems do participants have when receiving the Chocolate PTA balloon compared with standard balloon angioplasty?
Researchers will compare the Chocolate PTA balloon to standard plain old balloon angioplasty (POBA) to see if it improves vessel preparation before DCB therapy.
Participants will:
Undergo lesion preparation with either the Chocolate PTA balloon or standard balloon angioplasty, followed by DCB treatment
Have clinical and imaging follow-up visits to assess safety and vessel patency
Report any complications or adverse events throughout the study
Age ≥ 18 years
Indication for endovascular revascularization of the femoropopliteal artery
Rutherford Category 3, 4, or 5
De novo femoropopliteal lesion
Age < 18 years
No indication for endovascular revascularization of the femoropopliteal artery
Rutherford Category 0, 1, 2, or 6
Restenotic lesion
Felice Pecoraro
Lead sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Sponsor institution