The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.
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 or peripheral diagnostic or interventional procedure using a standard 6F 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, 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. The ECLIPSE Trial is designed to evaluate the safety and effectiveness of the Ensure Medical VCD in comparison to standard manual compression. Patients will be randomly assigned to have their arterial access site closed using either manual compression or the VCD. The principal comparisons of the two closure techniques will include: * Time required to obtain hemostasis of the vascular access site * Time required for the patient to ambulate after their catheterization * Frequency of occurrence of serious closure-related complications
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
488
Manual compression
Investigational vascular closure device
Mayo Clinic Hospital
Phoenix, Arizona, United States
University of California Davis Medical Center
Sacramento, California, United States
Time to Hemostasis (TTH)
Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.
Time frame: From when the introducer sheath was removed to the time hemostasis was first observed
Time to Ambulation (TTA)
Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.
Time frame: From when the introducer sheath was removed to 30 days post-procedure
Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure
Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (\> 30 days) access site-related nerve injury.
Time frame: From post-procedure to 30 days follow up
Time to Eligibility for Hospital Discharge
Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient's physician.
Time frame: From introducer sheath removal to hospital discharge, up to 284 hours
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Sutter Memorial Hospital
Sacramento, California, United States
Stanford University
Stanford, California, United States
Morton Plant Hosptial
Clearwater, Florida, United States
The Care Group
Indianapolis, Indiana, United States
Washington University School of Medicine at Barnes-Jewish Hospital
St Louis, Missouri, United States
Cooper Health Systems
Camden, New Jersey, United States
SJH Cardiology Associates
Liverpool, New York, United States
New York Presbyterian Hospital - Cornell Medical College of Cornell University
New York, New York, United States
...and 7 more locations
Time to Hospital Discharge
Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge
Time frame: From introducer sheath removal to patient discharge
Time to Device Deployment, up to 5 Minutes
Time to device deployment is defined as from the time device inserted to the time sheath removed
Time frame: From device inserted to introducer sheath removal
Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure
Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.
Time frame: Within 5 minutes post-procedure
Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure
Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint's closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.
Time frame: From catheterization procedure to 30 day post-procedure follow up
Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events
Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma \>= 6cm; Access Site-Related Bleeding Requiring \> 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse
Time frame: From end of vessel closure procedure to 30 days post-procedure