A Multicenter Study Comparing the Efficacy and Safety of 6F and 7F Thin-Walled Sheaths Via Distal Radial Artery Access for Coronary Intervention
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 574
- 试验地点
- 1
- 主要终点
- Radial Artery Occlusion Rate 24 Hours Post-Procedure
研究概览
简要总结
This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.
详细描述
This study is a multicenter, randomized controlled, prospective, non-inferiority, open-label clinical trial designed to compare the efficacy and safety of using 7F thin-walled sheaths versus 6F thin-walled sheaths for coronary intervention (PCI) via distal radial artery access (dTRA). The study will enroll adult patients with coronary artery disease who are scheduled to undergo PCI.
Participants will be randomized into two groups: the experimental group, which will receive PCI using a 7F sheath, and the control group, which will receive PCI using a 6F sheath. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure, assessed by ultrasound. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events during follow-up, cannulation success rate, PCI success rate, and the rate of radial artery occlusion at 30 days post-procedure, among others.
The study aims to determine whether the 7F sheath is non-inferior to the 6F sheath in terms of safety and efficacy for PCI through dTRA. The study will be conducted at multiple centers in China, with a planned enrollment of 574 participants, and it will span from Sep 2024 to January 2026. All procedures will adhere to the highest standards of clinical practice, and patient data will be managed with strict confidentiality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤80 years;
- •Height ≤180 cm;
- •Distal radial artery diameter ≥1.7 mm;
- •Completed distal radial artery angiography and requires coronary intervention;
- •Tolerates dual antiplatelet therapy and intraoperative anticoagulant therapy, with no history of related drug allergies;
- •Patient consents to participate in the study.
排除标准
- •Acute myocardial infarction requiring emergency PCI;
- •Ultrasound-confirmed occlusion of the radial artery on the procedure side;
- •Radial artery and distal radial artery anomalies (e.g., small caliber, tortuous, looped vessels) that make the dTRA approach unsuitable;
- •Previous bilateral radial artery intervention or surgery;
- •No coronary intervention performed after coronary angiography;
- •Inability to undergo coronary angiography and intervention due to subjective or objective reasons;
- •Coronary lesions requiring the use of a 7F guiding catheter;
- •Coronary arteries not suitable for 7F guiding catheter;
- •Severe liver or renal insufficiency, unresolved bleeding disorders, or other serious conditions with an expected survival of less than 1 year;
- •Currently breastfeeding or known pregnancy.
结局指标
主要结局
Radial Artery Occlusion Rate 24 Hours Post-Procedure
时间窗: 24 hours post-procedure
The primary outcome is the rate of radial artery and distal radial artery occlusion 24 hours after the procedure. Occlusion will be determined by the absence of blood flow spectrum in the radial artery as assessed by ultrasound.
次要结局
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(Up to 30 days post-procedure)
- Cannulation Success Rate(During the procedure)
- PCI Success Rate(During the procedure)
- Radial Artery Occlusion Rate 30 Days Post-Procedure(30 days post-procedure)
- Major Bleeding Events(Up to 30 days post-procedure)
- Local Neurological Complications(Up to 30 days post-procedure)
- Incidence and Severity of Forearm Hematoma(Up to 30 days post-procedure)
- Pain Scores(Up to 30 days post-procedure)
- Daily Living Ability Scores(Up to 30 days post-procedure)
- Length of Hospital Stay(From the time of admission for the procedure until the date of discharge, assessed up to 30 days post-procedure)
- Unplanned Additional Interventions During Hospitalization(From the time of procedure until discharge, assessed up to 30 days post-procedure)