Hermiller J B, Simonton C, Hinohara T, Lee D, Cannon L, Mooney M, O'Shaughnessy C, Carlson H, Fortuna R, Zapien M, Fletcher D R, DiDonato K, Chou T M
St. Vincent's Hospital, Indianapolis, Indiana, USA.
Catheter Cardiovasc Interv. 2006 Nov;68(5):677-83. doi: 10.1002/ccd.20922.
The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures.
A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis.
The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different.
The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.
StarClose血管闭合系统是一种股动脉穿刺部位闭合技术，它使用一个可弯曲的镍钛合金夹子完成血管周围的血管切开术闭合。开展Clip CLosure In Percutaneous Procedures研究以评估StarClose装置在接受诊断性和介入性导管插入术的受试者中的安全性和有效性。
美国共有17个研究点招募了596名受试者，其中483名受试者按2:1的比例随机分组，在经皮手术后接受StarClose装置或动脉切开术标准压迫止血。该研究包括纳入组（n = 113）、诊断组（n = 208）和介入组（n = 275），主要安全终点为30天内的主要血管并发症，主要疗效终点为术后止血时间。
诊断性StarClose队列的结果已单独报告。介入组的结果显示，StarClose组1.1%（2/184）的受试者发生主要血管并发症，手动压迫组为1.1%（1/91；P = 1.00）。两组均未出现感染。StarClose介入组的轻微并发症发生率为4.3%（8/184），压迫组为9.9%（9/91；P = 0.107）。StarClose组未出现假性动脉瘤或动静脉瘘。对于StarClose，诊断组的手术成功率为100%（136/136），介入组为98.9%（181/183）。治疗组的装置成功率为86.8%。在介入队列中，87.3%（158/181）的StarClose组受试者报告疼痛评分为0 - 3，压迫组为93.3%（84/90），差异无统计学意义。
本研究的临床结果表明，在接受经皮介入手术的受试者中，就主要血管事件的主要安全终点而言，StarClose血管闭合系统不劣于手动压迫止血。与压迫止血相比，StarClose显著缩短了止血时间、下床活动时间和出院时间。
