Advance Evero™ 18 Everolimus-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Versus Paclitaxel-coated Ballons in Patients With Femoropopliteal Disease (EVERO Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 410
- 试验地点
- 10
- 主要终点
- Primary safety endpoint
研究概览
简要总结
The primary objective of the study is to evaluate the long-term safety and effectiveness of the Advance Evero™ 18 Everolimus-coated Percutaneous Transluminal Angioplasty Balloon Catheter (hereafter referred to as the Evero drug-coated balloon [DCB]) in the treatment of the femoropopliteal artery lesions in patients with peripheral arterial disease (PAD). Specifically, the Randomized-Controlled Trial (RCT) is designed to demonstrate non-inferior safety and non-inferior effectiveness of the Evero DCB when compared to commercially available paclitaxel DCBs (pDCBs).
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
- Double (Participant, Outcomes Assessor)
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
- •Documented PAD with Rutherford classification 2 - 4; and
- •De novo or restenotic (non-stented) target lesion located in the native superficial femoral artery (SFA), popliteal artery (P1 or P2), or both native SFA and popliteal arteries.
排除标准
- •General Exclusion Criteria
- •Less than 18 years old;
- •Inability or refusal to give informed consent by the patient or legally authorized representative;
- •Life expectancy ≤ 12 months, per investigator assessment;
- •Pregnant (or if absence of pregnancy is not verified by negative pregnancy test within 7 days of planned procedure), lactating, planning to become pregnant within 12 months of the planned procedure, or unwilling to use contraception for 12 months following the planned procedure;
- •Unable or unwilling to comply with the follow-up schedule; or
- •Simultaneously participating in another investigational drug or device study unless the patient is at least 30 days beyond the primary endpoint of any previous study.
研究组 & 干预措施
Paclitaxel-coated DCB
Treatment with commercially-available drug-coated balloons to apply local treatment with paclitaxel
干预措施: Paclitaxel DCB (Combination Product)
Evero DCB
Treatment with Evero drug-coated balloon to apply local treatment with everolimus
干预措施: Evero DCB (Combination Product)
结局指标
主要结局
Primary safety endpoint
时间窗: 30 days (death); 12 months (amputation and CD-TLR)
The primary safety endpoint is a composite assessment of freedom from device- or procedure-related death, freedom from target limb major amputation, and freedom from clinically-driven target lesion revascularization (CD-TLR)
Primary effectiveness endpoint
时间窗: 12 months
The primary effectiveness endpoint is primary patency defined as peak systolic velocity ratio ≤2.4 assessed by duplex ultrasound at 12 months and freedom from CD-TLR.
次要结局
未报告次要终点