DISCO Radial Trial: DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention: a Randomized Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,309
- 试验地点
- 31
- 主要终点
- Forearm radial artery occlusion (RAO) rate before discharge
研究概览
简要总结
The objective of this study is to demonstrate the superiority of Distal Radial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO).
This trial plans to include 1300 patients in around 12 locations around the world (11 participating sites in Europe and 1 participating site in Japan).
详细描述
DISCO RADIAL is a prospective, global, open label, multi-centre randomized controlled trial with plan to include approximately 1300 patients on who transradial coronary angiography and/or intervention is performed. The patients will be randomized in 1:1 ratio to either Distal Transradial Artery Access (DTRA) or Conventional Transradial Access (CTRA) arm. In both arms 6Fr Glidesheath Slender (GSS) will be used as access sheath.
The sponsor will work in accordance with standard operating procedures (SOP) and the Monitoring Plan in order to ensure adherence to the CIP and applicable regulations at the investigational sites.
The Monitoring Plan is built according to a risk-based monitoring approach and describes the level of source data verification to be performed by the monitors.
Risk-based monitoring approach uses all available means to supervise the trial (central monitoring, remote monitoring and on-site monitoring), focusing in critical data points and issues ensuring that adequate monitoring (central, remote and on-site) at each site is completed to ensure protection of the rights and safety of the subjects and the quality and integrity of the data collected and submitted.
The sponsor shall provide training and the necessary guidelines to assist each investigational site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality and avoid missing information in the eCRF, edit checks are designed during database development. In addition, Sponsor's CRA and Data Management team will be responsible to review the data and raise queries accordingly into the eCRF. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patient is at least 18 years of age.
- •Patient has provided written informed consent.
- •Patient is undergoing diagnostic coronary angiography and/or PCI.
- •Patient is willing to comply with all protocol-required evaluations during the hospitalization.
- •Patient is suitable for both DTRA and CTRA using 6Fr GSS.
排除标准
- •Patient has a medical condition that may cause non-compliance with the protocol and/or confound the data interpretation.
- •Patients on chronic hemodialysis.
- •Patients presenting with ST-elevated myocardial infarction (STEMI).
- •Patients have chronic total occlusion (CTO) lesions in coronary artery.
结局指标
主要结局
Forearm radial artery occlusion (RAO) rate before discharge
时间窗: up to 5 days
Forearm radial artery occlusion (RAO) rate before discharge measured with Doopler Ultrasound
次要结局
- Sheath insertion time(up to 2 days)
- Overall bleeding according to BARC criteria(up to 5 days)
- Rate of successful sheath insertion(up to 2 days)
- Total procedural time(up to 2 days)
- Patent hemostasis was achieved or not (CTRA) by reverse barbeau test(up to 5 days)
- Pain associated with the procedure: Visual Assessment Scale (VAS)(up to 5 days)
- Rate of access site crossover(up to 2 days)
- Vascular access-site complication(up to 5 days)
- Rate of distal radial artery occlusion (dRAO)(up to 5 days)
- Puncture site bleeding according to EASY criteria(up to 5 days)
- Rate of radial artery spasm(up to 2 days)
- Time required to reach hemostasis(up to 5 days)