Peripheral Registry of Endovascular Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Amputation free survival rates
研究概览
简要总结
The PRIME Registry is a multi-center, observational study designed to evaluate immediate and long-term outcomes (36 months) of endovascular revascularization in patients with critical limb ischemia (CLI) and advanced peripheral artery disease (PAD).
详细描述
The Peripheral RegIstry of Endovascular Clinical OutcoMEs (PRIME Registry) represents the collaborative effort among seven centers across the US with the goal of reaching 10 sites globally. PRIME explores all aspects of advanced peripheral arterial disease (PAD) and critical limb ischemia (CLI) care including the collection of comprehensive clinical, diagnostic, procedural, and follow-up data for three years following an index endovascular procedure. Data collection activities began in January of 2013 with the goal of collecting data on 1500 subjects. Analysis of this multi-site registry will produce generalizable findings that describe the clinical epidemiology and management practices of advanced PAD and CLI patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who are to receive or have received lower extremity endovascular intervention
- •Rutherford III-VI Classification
- •Ability to provide informed consent within 30 day prior to 60 days post index endovascular intervention.
- •Ability to follow up at enrollment site.
排除标准
- •Inability or unwillingness to consent for participation in the registry.
结局指标
主要结局
Amputation free survival rates
时间窗: At 36 month follow-up visit
次要结局
- Access site and procedural complications(At 36 month follow-up visit)
- Target lesion revascularization(At 36 month follow-up visit)
- Procedural success(At 36 month follow-up visit)
- Target vessel revascularization(At 36 month follow-up visit)