NCT00852176Unknown不适用
Best Vascular P000018 Post-approval Study: Retrospective Long-term Safety and Efficacy Study of the Beta-Cath(TM) 3.5F System
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events (MACE)
研究概览
简要总结
The study will evaluate the long-term safety and efficacy of intravascular beta radiation therapy to treat coronary in-stent restenosis using the Beta-Cath(TM) 3.5F System; data will be collected retrospectively on patients treated with the Beta-Cath™ 3.5F System in routine clinical practice following FDA pre-market approval of the System. Outcomes will be reported up to 5 years following treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent on-label treatment (as defined below) with the Beta-Cath™ 3.5F System (30, 40 or 60mm) for in-stent restenosis (ISR) after coronary stenting.
- •On-label treatment for the 30 and 40mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with discrete lesions (treatable with a 20mm balloon) in reference vessel diameters (RVD) ranging from 2.7mm to 4.0mm
- •On-label treatment for the 60mm Beta-Cath™ 3.5F System is defined as: treatment of ISR in native coronary arteries with lesions <40mm in length in RVD ranging from 2.7mm to 4.0mm
- •Patients must have undergone brachytherapy treatment at least 6-8 months prior to enrollment in this retrospective study and the date of their treatment must be:
- •On or after February 8, 2002 for the 30/40mm 3.5F System
- •On or after June 25, 2003 for the 60mm 3.5F System
排除标准
- •Patients who do not give informed consent
- •Patients who do not meet the inclusion criteria
结局指标
主要结局
Major Adverse Cardiac Events (MACE)
时间窗: In-hospital and at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-treatment
Major Adverse Cardiac Events (MACE)
次要结局
- Incidence of device-related procedural events(At time of intervention)
- Device success, including successful delivery of the Beta-Cath(TM) 3.5F System radiation source train, return of the radiation source train, and delivery of the intended dose(At time of intervention)
- Target Vessel Revascularization (TVR)(6 months; 1, 2, 3, 4, and 5 years post-treatment)
研究者
研究点 (1)
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