Feasibility Study of the 7F Ensure Medical Plug Arterial Closure System (PACS, 7F)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Angioplasty, Transluminal, Percutaneous Coronary
- Sponsor
- Cordis Corporation
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Time to hemostasis following vessel access site closure
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Scheduled for a coronary diagnostic or interventional procedure
- •Able to undergo emergent vascular surgery if a complication requires it
- •7F arterial puncture located in the common femoral artery
- •Femoral artery has a lumen diameter of at least 5 mm
Exclusion Criteria
- •Arterial puncture in the femoral artery of both legs
- •Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization
- •Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders
- •Acute ST-elevation myocardial infarction within 48 hours prior to catheterization
- •Uncontrolled hypertension at time of vessel closure
- •Elevated Activated Clotting Time at time of vessel closure
- •Ineligible for in-catheterization lab introducer sheath removal
- •Concurrent participation in another investigational device or drug trial
- •Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization
- •Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure
Outcomes
Primary Outcomes
Time to hemostasis following vessel access site closure
Time Frame: 5 minutes post procedure
Time to ambulation following vessel access site closure
Time Frame: Post-procedure
Combined rate of closure related major adverse events at 30 days
Time Frame: Through 30 days
Secondary Outcomes
- Device success (initial hemostasis within 5 minutes)(Within 5 minutes)
- Procedural success on day of catheterization and at 30 days (initial hemostasis by non-randomized treatment without closure related serious adverse events)(Through 30 days)
- Time patient is deemed eligible for hospital discharge relative to their access site closure(Up to hospital discharge)
- Time patient is discharged from the hospital(Patient discharge)
- Known events associated with vascular closure devices(Through 30 days)