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
Parallel
Chocolate PTA Balloon
DeviceParticipants undergo lesion preparation with the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon prior to drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed according to standard practice.
Standard Balloon Angioplasty (POBA)
DeviceParticipants undergo lesion preparation with standard plain old balloon angioplasty (POBA) prior to drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed according to standard practice.
Primary Patency at 12 Months
Proportion of target femoropopliteal lesions maintaining primary patency without stent placement. Primary patency is defined as PSVR ≤ 2.4 on duplex ultrasound at 12 months.
Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 12 Months
Proportion of patients who do not require re-intervention on the target lesion within 12 months after the index procedure.
Assisted Primary Patency at 12 Months
Proportion of lesions that remain patent without requiring bailout stenting within 12 months after the index procedure.
Post-Angioplasty Dissections (PADS)
Incidence and severity (all grades and severe types C-F) of dissections following balloon angioplasty.
Bailout Stenting Rate
Proportion of lesions requiring rescue stent placement after balloon angioplasty.
Device Success / Failure of Chocolate Balloon
Incidence of balloon failure or damage during lesion preparation with the Chocolate PTA balloon.
Clinical Improvement (Rutherford Category)
Change in Rutherford category to evaluate clinical improvement in limb ischemia symptoms.
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Felice Pecoraro
Lead sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
