• Composite of major vascular complications necessitating surgical or percutaneous repair. [ Time Frame: 30-days after randomization ] [ Designated as safety issue: Yes ]
  

• The time to hemostasis. [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  
• Procedure time. [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  
• Device success. [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  
• Procedure success. [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  
• Time to ambulation. [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  
• Time to discharge. [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  
• Subject's comfort level during the deployment of the StarClose using the 11-point Box Scale (BS-11). [ Time Frame: 30-days after treatment ] [ Designated as safety issue: Yes ]
  

The growing success of interventions and requirement for day case or outpatient procedures has led to a concomitant rise in the use of arteriotomy closure devices (ACD) to achieve hemostasis and allow early mobilization following arterial punctures. ACD have emerged as an alternative to traditional mechanical compression after percutaneous coronary intervention (PCI). When compared to manual compression, several studies have confirmed patient comfort, reduced time to achieve hemostasis, reduced time to ambulation, and early discharge.

Recently, CLIP Trial was conducted to evaluated 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. This trial demonstrated 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. However, there are no studies randomly comparing these two closure devices. Therefore, this study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).