BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular Devices, Redwood City, California) utilizes a small, flexible nitinol clip to complete a circumferential, extravascular closure of the femoral arteriotomy site. The StarClose is an investigational device in the United States, limited by Federal law to investigational use. The StarClose is CE Mark approved. METHODS: The CLIP study was a prospective, randomized, multicenter trial utilizing a noninferiority design to compare the rate of major vascular complications and time-to-hemostasis using the StarClose system versus manual compression. A total of 596 subjects were enrolled, 208 of whom underwent diagnostic angiography. This diagnostic subset is the focus of this report. The primary safety endpoint was major vascular complications and the primary efficacy endpoint was time-to-hemostasis. All patients were followed at 30 days with a clinical exam. RESULTS: Subjects were randomized 2:1 to the StarClose (n = 136) or manual compression (n = 72). There were no major vascular complications in either group. Minor vascular complications occurred in 3 StarClose patients (2.2%), and 1 manual compression patient (1.4%) (p = 1.00). Use of the StarClose device reduced mean time-to-hemostasis from 15.47 +/- 11.4 to 1.46 +/- 4.5 minutes (p < 0.001) when compared to manual compression, and reduced the average time-to-ambulation from 269 +/- 135 to 163 +/- 105 minutes (p < or = 0.001). Device success was 94.1% (127/135), and procedural success was 100% (136/136). CONCLUSION: The clinical results of this study concluded that the StarClose Vascular Closure System is noninferior to standard compression with respect to the the primary safety endpoint of closing arteriotomies in patients who undergo percutaneous diagnostic procedures.
RCT Entities:
BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular Devices, Redwood City, California) utilizes a small, flexible nitinol clip to complete a circumferential, extravascular closure of the femoral arteriotomy site. The StarClose is an investigational device in the United States, limited by Federal law to investigational use. The StarClose is CE Mark approved. METHODS: The CLIP study was a prospective, randomized, multicenter trial utilizing a noninferiority design to compare the rate of major vascular complications and time-to-hemostasis using the StarClose system versus manual compression. A total of 596 subjects were enrolled, 208 of whom underwent diagnostic angiography. This diagnostic subset is the focus of this report. The primary safety endpoint was major vascular complications and the primary efficacy endpoint was time-to-hemostasis. All patients were followed at 30 days with a clinical exam. RESULTS: Subjects were randomized 2:1 to the StarClose (n = 136) or manual compression (n = 72). There were no major vascular complications in either group. Minor vascular complications occurred in 3 StarClosepatients (2.2%), and 1 manual compression patient (1.4%) (p = 1.00). Use of the StarClose device reduced mean time-to-hemostasis from 15.47 +/- 11.4 to 1.46 +/- 4.5 minutes (p < 0.001) when compared to manual compression, and reduced the average time-to-ambulation from 269 +/- 135 to 163 +/- 105 minutes (p < or = 0.001). Device success was 94.1% (127/135), and procedural success was 100% (136/136). CONCLUSION: The clinical results of this study concluded that the StarClose Vascular Closure System is noninferior to standard compression with respect to the the primary safety endpoint of closing arteriotomies in patients who undergo percutaneous diagnostic procedures.