A Post-Approval Evaluation of the PALMAZ MULLINS XD™ Pulmonary Stent in the Treatment of Pulmonary Artery Stenosis (REALPASS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 主要终点
- Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
研究概览
简要总结
The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.
详细描述
The clinical study is a prospective, single-arm, multi-center, post-approval study of all consecutive subjects treated with the PALMAZ MULLINS XD™ Pulmonary Stent. The study will enroll a minimum of 35 subjects and a maximum of 75 subjects in up to 11 U.S sites or until the end of the 2-year enrollment period has been reached, whichever comes first.
The study will collect the performance and safety data of the PALMAZ MULLINS XD™ Pulmonary Stent through time of hospital discharge.
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
- — 至 21 Years（Child, 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
Technical Success (Successful use of the study device without additional, unplanned device or procedure-related surgery/re-intervention)
时间窗: Start time of index procedure through time of discharge/study completion, usually within ~48 hours from end time of index procedure
1. Successful access, delivery and retrieval of the device delivery system, 2. Deployment and correct positioning of the device in the intended location, and 3. No need for additional, unplanned surgery or re-intervention related to the device or access procedure.
Patency (Angiographically-determined increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter)
时间窗: Index procedure (start time to end time)
Increase in stented vessel minimum pulmonary artery diameter by ≥ 50% of the pre-stent diameter determined by post-implant angiography.
Safety Outcome (Incidence of Treatment-Emergent Serious Adverse Events)
时间窗: Time of enrollment (device implant during index procedure) through time of discharge/study completion, usually within ~48 hours from end time of index procedure
Device or procedure-related, serious adverse events reported through time of hospital discharge, which meet any of the following criteria: 1. Led to a death, 2. Led to a serious deterioration in health of the subject, that either resulted in 1. Life-threatening illness or injury, or 2. Hospitalization (initial or prolonged) or 3. Disability or permanent impairment of a body structure or a body function or 4. Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. Other Serious (important) Medical Events
次要结局
未报告次要终点