NCT07471087

Chocolate Balloon vs Standard Balloon Angioplasty Before Drug-Coated Balloon Treatment for Femoropopliteal Artery Narrowing or Blockage

Multicenter Randomized Controlled Trial Comparing Chocolate Percutaneous Transluminal Angioplasty Balloon Versus Plain Old Balloon Angioplasty for Vessel Preparation Prior to Drug-Coated Balloon Treatment in Patients With Femoropopliteal Stenotic or Occlusive Lesions.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Felice Pecoraro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Peripheral Artery Disease (PAD)
• Femoropopliteal Artery Disease
• Vascular Lesion Preparation
• Critical Limb-Threatening Ischemia

Interventions

Type	Name	Description
DEVICE	Chocolate PTA Balloon	Participants 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.
DEVICE	Standard Balloon Angioplasty (POBA)	Participants 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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2026-03-13
• Last updated: 2026-03-13