NCT02026466已完成不适用
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 11
- 主要终点
- Health Status
研究概览
简要总结
This is an observational registry, sponsored by Saint Luke's Hospital. This study is to be conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies and procedures. The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.
详细描述
- 1,000 participants will be enrolled into the OPEN CTO study.
- Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.
- Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.
- Participants will be screened for Eligibility, and Informed Consent will be obtained.
- Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.
- Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.
- Participants will undergo a Baseline interview.
- These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.
- Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital.
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
- •Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.
- •Subject is ≥ 18 years of age at the time of consent.
排除标准
- •The CTO segment is in a graft
- •Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
- •Non-English speaking
- •Too hard of hearing to do follow-up by telephone.
- •Previously enrolled in OPEN CTO Registry
- •Currently a prisoner
- •Subjects with no way contact by telephone for follow-up.
结局指标
主要结局
Health Status
时间窗: One year
Quantify the baseline health status effects of CTO among patients selected for CTO-PCI and quantify the changes associated with CTO-PCI using the Hybrid Approach.
次要结局
- Safety and Effectiveness(One Year)
研究者
研究点 (11)
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