Plug Arterial Closure System (PACS, 7F) (PACS 7F)
The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional coronary procedures using a standard 7F introducer sheath.
Angioplasty, Transluminal, Percutaneous Coronary
Device: Vascular access site closure (7F Ensure)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study of the 7F Ensure Medical Plug Arterial Closure System (PACS, 7F)|
- Time to hemostasis following vessel access site closure [ Time Frame: 5 minutes post procedure ] [ Designated as safety issue: No ]
- Time to ambulation following vessel access site closure [ Time Frame: Post-procedure ] [ Designated as safety issue: No ]
- Combined rate of closure related major adverse events at 30 days [ Time Frame: Through 30 days ] [ Designated as safety issue: Yes ]
- Device success (initial hemostasis within 5 minutes) [ Time Frame: Within 5 minutes ] [ Designated as safety issue: No ]
- Procedural success on day of catheterization and at 30 days (initial hemostasis by non-randomized treatment without closure related serious adverse events) [ Time Frame: Through 30 days ] [ Designated as safety issue: No ]
- Time patient is deemed eligible for hospital discharge relative to their access site closure [ Time Frame: Up to hospital discharge ] [ Designated as safety issue: No ]
- Time patient is discharged from the hospital [ Time Frame: Patient discharge ] [ Designated as safety issue: No ]
- Known events associated with vascular closure devices [ Time Frame: Through 30 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||August 2007|
Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular complications. Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression or the deployment of a vascular closure device. Manual compression is time consuming for the health-care provider, and painful for the patient. In addition, prolonged periods of immobilization and bed rest may be required. Vascular closure devices have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site closure in patients who have undergone coronary catheterizations using a standard 7F introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery system. The plug delivery system is designed to position the bio-absorbable plug to the extravascular surface of the femoral artery access site, facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients utilizing a 6F introducer sheath, which demonstrated that: (1) the device could be used to successfully obtain rapid hemostasis and early ambulation in patients undergoing catheterization procedures; and (2) the low incidence and relatively minor nature of the observed closure related complications suggests that the device is safe for its intended purpose.