Feasibility of Percutaneous Coronary Intervention Using a 7-Fr Thin Walled Sheath Via the Distal Radial Approach: a Prospective Observational Study (SEVEN-BOX)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Access site complication during hospitalization and within 1-month follow-up
研究概览
简要总结
To evaluate the safety and effectiveness of percutaneous coronary intervention using a 7-French(Fr) thin-walled sheath via the distal radial approach
详细描述
Recently, coronary angiography (CAG) and percutaneous coronary intervention (PCI) via the distal radial artery access (DRA) have shown several advantages owing to fewer complications, such as radial artery occlusion, pseudoaneurysms, and arteriovenous(AV) fistulas, and short hemostasis duration than the proximal radial access (PRA). However, despite the potential advantages of the DRA, there are still many cardiologists who prefer the femoral approach for complex PCI including left main disease, bifurcation lesions, heavily calcified lesions, which need a strong backup and using several devices. The radial artery and the distal radial artery have a smaller diameter than the femoral artery, and interventional cardiologists are usually performed using the 6-Fr sheath. The previously developed 7-Fr sheath has a higher risk of vascular occlusion when use in a radial artery due to larger diameter compared to radial artery in 30% to 60% of patients. However, with the recent development of various technologies, the outer diameter of the sheath is gradually becoming thinner and recently a 7-Fr thin-walled sheath which does not differ significantly from the outer diameter of the 6-Fr sheath used in the previously PRA demonstrated that feasibility and safety for radial artery intervention. Despite the feasibility and potential benefits of the DRA and 7-Fr thin-walled sheath for radial artery, there is a lack of data regarding the safety and efficacy of a 7-Fr thin-walled sheath during the DRA.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, ≥ 19 years of age, who were diagnosed with ischemic heart disease requiring percutaneous coronary intervention (PCI)
- •Patients who are palpable distal radial artery
- •The decision to participate voluntarily in this study and the written consent of the patient
- •Patients who planned to perform PCI using a 7-Fr thin-walled sheath
排除标准
- •Patients who are not palpable distal radial artery
- •Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study
- •Pregnancy
- •Patients who are not appropriate for this study
结局指标
主要结局
Access site complication during hospitalization and within 1-month follow-up
时间窗: Through procedure completion, up to 1month
bleeding(defined by BARC criteria), hematoma (using modified EASY\[Early Discharge After Transradial Stenting of Coronary Arteries Study\] classification: A) Grade Ia hematoma was subclassified into 4 grades from the puncture site \[Grade 1, \<2cm; Grade2, 2-5cm; Grade3,\>5cm; and grade 4, hand swelling\], B) Grade Ib, wrist \< 5cm, C) Grade II, wrist \< 10cm, D) Grade III, forearm, E) Grade IV, upper arm), numbness, AV fistula, Pseudoaneurysm, and conventional and distal radial artery occlusion (assessed by manual palpation or ultrasonography\[prefer\])
Success rate of PCI
时间窗: Through procedure completion, up to 1month
Success rate of PCI using 7-Fr sheath via the distal radial approach (%)
次要结局
- Patency of distal radial artery after 1 month(Time Frame: up to 1month)
- Hemostasis duration(Through procedure completion, up to 24 hours)
- Patency of proximal radial artery after hemostasis(Through procedure completion, up to 24 hours)
研究者
Yongcheol Kim
Director head of snuffbox center in Yongin Severance Hospital, Principal Investigator, Clinical Professor
Yonsei University