A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Vonapanitase Administered Following Angioplasty of a Distal Popliteal, Tibial or Peroneal Artery in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 9
- 主要终点
- Technical success of perivascular injection
研究概览
简要总结
The research study is designed to assess the technical feasibility and safety of a perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal popliteal, tibial or peroneal arteries immediately following successful angioplasty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（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
研究组 & 干预措施
Vonapanitase
Vonapanitase administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
干预措施: vonapanitase (Drug)
Placebo
Placebo administered to the distal popliteal, tibial or peroneal artery using a micro-infusion catheter.
干预措施: Placebo (Drug)
结局指标
主要结局
Technical success of perivascular injection
时间窗: Intraprocedural
Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scale
Incidence of adverse events
时间窗: Up to 6 months following study drug administration
Safety assessments include physical exams and routine serum chemistry and hematology tests
次要结局
未报告次要终点