RECCORD - Recording Courses of Vascular Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Quality of Life: EQ-5D-5L questionnaire
研究概览
简要总结
The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform.
In the initial phase, patients referred for endovascular revascularization of peripheral artery disease (PAD) of the lower limbs will be prospectively included and followed up for at least one year.
At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed.
Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits.
For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa. https://doi.org/10.1024/0301-1526/a000631
详细描述
For details see NM Malyar et al., Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •any type of endovascular interventions for symptomatic PAD
- •endovascular intervention for PAD of lower extremities, i.e. below the aorto-iliac bifurcation
排除标准
- •patients undergoing hybrid-(surgical and endovascular) and/or surgical interventions for symptomatic PAD
- •patients with a life expectancy of <6 months
- •endovascular intervention for reasons other than symptomatic PAD
结局指标
主要结局
Quality of Life: EQ-5D-5L questionnaire
时间窗: At baseline, at 6 and 12 months
EQ-5D-5L questionnaire to asses patient's health state and patient's self-rated health
Outcome Quality after Revascularization: Complications
时间窗: Up to 1 month
Peri- and post-interventional complications (puncture-site complications \& intervention-related complications over 30 days
Outcome Quality after Revascularization: Re-Intervention
时间窗: Up to 12 months
Number of re-interventions
Outcome Quality after Revascularization: Amputation
时间窗: Up to 12 months
Amputation-free survival (AFS)
Outcome Quality after Revascularization: Survival
时间窗: Up to 12 months
Survival at one year in CLI patients
次要结局
未报告次要终点