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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 242
- 主要终点
- Primary Patency at 12 Months
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial. No parties are masked. Both the investigators performing the procedure and the participants are aware of the assigned intervention. All procedural and safety outcomes are assessed according to standard practice, and any imaging or clinical follow-up is performed without masking.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Indication for endovascular revascularization of the femoropopliteal artery
- •Rutherford Category 3, 4, or 5
- •De novo femoropopliteal lesion
- •Stenosis ≥ 70% or chronic total occlusion (CTO)
- •Any degree of calcification
- •Any lesion length
- •At least one patent infrapopliteal vessel to the foot
- •Expected life expectancy > 12 months
排除标准
- •Age < 18 years
- •No indication for endovascular revascularization of the femoropopliteal artery
- •Rutherford Category 0, 1, 2, or 6
- •Restenotic lesion
- •Absence of at least one patent infrapopliteal vessel to the foot
- •Inability to complete the planned follow-up
- •Life expectancy < 12 months
- •Pregnancy
研究组 & 干预措施
Chocolate PTA Balloon
Participants undergo lesion preparation with the Chocolate Percutaneous Transluminal Angioplasty (PTA) balloon before receiving drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed following standard practice.
干预措施: Chocolate PTA Balloon (Device)
Standard Balloon Angioplasty (POBA)
Participants undergo lesion preparation with standard plain old balloon angioplasty (POBA) before receiving drug-coated balloon (DCB) angioplasty. Procedural outcomes, vessel patency, and safety will be assessed following standard practice.
干预措施: Standard Balloon Angioplasty (POBA) (Device)
结局指标
主要结局
Primary Patency at 12 Months
时间窗: 12 months from index procedure
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
时间窗: 12 months from index procedure
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
时间窗: 12 months from index procedure
Proportion of lesions that remain patent without requiring bailout stenting within 12 months after the index procedure.
次要结局
- Device Success / Failure of Chocolate Balloon(During procedure)
- Post-Angioplasty Dissections (PADS)(Perioperative/Periprocedural)
- Bailout Stenting Rate(Perioperative/Periprocedural)
- Clinical Improvement (Rutherford Category)(1, 6, and 12 months follow-up)
- Major Adverse Events (MAE) and Safety(12 months from index procedure)
- Final Evaluation at 12 Months(12 months from index procedure)
研究者
Felice Pecoraro
Professor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo