X-Pand is Intended to Use the DESolve Scaffold System in Treatment of CAD Patients, by Including "Real World" Use of the DESolve Scaffold Over a Broad Spectrum of Geographies, A Wide Variety of Practicing Clinicians & A Minimum Degree Of Selection Criteria
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 154
- 试验地点
- 5
- 主要终点
- TLF (Target Lesion Failure)
研究概览
简要总结
The X-Pand Registry is intended to facilitate analysis of acute & long-term safety as well as treatment outcomes with DESolve in patients with CAD.
详细描述
The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold.
The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines & internal hospital guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Minimal age 18 years
- •Patient is willing/able to cooperate with study procedures and required follow up visits. Patient or legal representative has been informed & agrees by signing EC approved written consent. Consent can occur before implantation of the DESolve scaffold (planned procedure) or within 30 days post implantation procedure for retrospective enrollment (unplanned procedure).
- •Planned or unplanned DESolve scaffold implantation
排除标准
- 未提供
结局指标
主要结局
TLF (Target Lesion Failure)
时间窗: 12 months
TLF is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)
Death
时间窗: 12 months
All cause mortality
CD-TVR
时间窗: 12 months
Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)
CABG
时间窗: 12 months
Emergency bypass surgery (CABG)
MI
时间窗: 12 months
Myocardial Infarction
次要结局
- MACE(3 years)
- Device Success(day of treatment procedure)
- Procedure Success(30 days)
- Thrombosis(12 months)