A Prospective, Multi-Center, Single-Arm, Feasibility Study to Assess the Safety and Performance WIth the SUNDANCE™ DruG Coated Balloon for the Treatment of De Novo or Restenotic Lesions in Infra-Popliteal Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Primary Safety Endpoint: Number of Participants with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death
研究概览
简要总结
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
详细描述
SWING is a prospective, multi-center, single-arm, feasibility study to assess the safety and performance of the Sundance™ drug coated balloon for the treatment of de novo or restenotic lesions in infra-popliteal Arteries. Approximately 35 subjects will be treated at up to 8 sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary Safety Endpoint: Number of Participants with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death
时间窗: 30 Days
MALE is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major amputation is defined as limb amputation above the ankle. Major re-intervention is defined as the creation of new surgical bypass graft, the use of thrombectomy or thrombolysis, or major surgical graft revision such as a jump graft or an interposition graft.
Primary Efficacy Endpoint: Rate of Late Lumen Loss (LLL)
时间窗: 6 Months
LLL is assessed by quantitative vascular angiography (QVA). LLL is the difference between minimum lumen diameter (MLD) immediately after PTA and MLD at 6 months follow-up.
次要结局
- Rate of Technical Success(Acute/Periprocedural)
- Rate of Restenosis(6 Months or prior)
- Walking Impairment Questionnaire (WIQ)(30 Days, 6 Months, 12 Months, 24 Months)
- Major Adverse Event (MAE) rate(30 Days, 6 Months, 12 Months, 24 Months)
- Change in Rutherford-Becker Classification(30 Days, 6 Months, 12 Months, 24 Months)
- Rate of Device Success(Acute/Periprocedural)
- Rate of Procedure Success(Acute/Periprocedural)
- Amputation Free Survival(6 Months, 12 Months, 24 Months)
- EQ-5D(30 Days, 6 Months, 12 Months, 24 Months)
- Number of Participants with Primary Patency(30 Days, 6 Months, 12 Months, 24 Months)
- Hemodynamic outcomes(30 Days, 6 Months, 12 Months, 24 Months)
- Vascular Quality of Life Questionnaire (VascuQol)(30 Days, 6 Months, 12 Months, 24 Months)