Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00345631
First received: June 26, 2006
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Arteriosclerosis
Peripheral Arteriosclerosis
Other: Manual Compression
Device: Vascular Closure Device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Time to Hemostasis (TTH) [ Time Frame: From when the introducer sheath was removed to the time hemostasis was first observed ] [ Designated as safety issue: No ]
    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 to Ambulation (TTA) [ Time Frame: From when the introducer sheath was removed to 30 days post-procedure ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure [ Time Frame: From post-procedure to 30 days follow up ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Time to Eligibility for Hospital Discharge [ Time Frame: From introducer sheath removal to hospital discharge, up to 284 hours ] [ Designated as safety issue: Yes ]
    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 to Hospital Discharge [ Time Frame: From introducer sheath removal to patient discharge ] [ Designated as safety issue: No ]
    Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge

  • Time to Device Deployment, up to 5 Minutes [ Time Frame: From device inserted to introducer sheath removal ] [ Designated as safety issue: No ]
    Time to device deployment is defined as from the time device inserted to the time sheath removed

  • Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure [ Time Frame: Within 5 minutes post-procedure ] [ Designated as safety issue: No ]
    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.

  • Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure [ Time Frame: From catheterization procedure to 30 day post-procedure follow up ] [ Designated as safety issue: No ]
    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.

  • Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events [ Time Frame: From end of vessel closure procedure to 30 days post-procedure ] [ Designated as safety issue: Yes ]
    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


Enrollment: 488
Study Start Date: February 2007
Study Completion Date: September 2007
Arms Assigned Interventions
Active Comparator: Manual Compression
Manual compression (MC)
Other: Manual Compression
Manual compression
Experimental: Vascular Closure Device
Vascular Closure Device (VCD)
Device: Vascular Closure Device
Investigational vascular closure device
Other Name: Exoseal

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 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
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled for a coronary or peripheral diagnostic or interventional procedure
  • Able to undergo emergent vascular surgery if a complication requires it
  • 6F 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
  • Prior femoral vascular surgery or vascular graft in region of access site
  • Femoral artery is tortuous or requires an introducer sheath longer than 11 cm
  • Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site that would interfere with the operation of the experimental device
  • Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
  • Antegrade vascular puncture
  • Body Mass Index over 40 kg/m^2
  • Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse
  • Femoral artery diameter stenosis exceeding 50%
  • Pre-existing severe non-cardiac systemic disease or terminal illness
  • Planned arterial access at the same access site within 30 days of catheterization
  • Extended hospitalization (e.g. Coronary Artery Bypass Graft (CABG) surgery)
  • Pre-existing systemic or cutaneous infection
  • Prior use of an intra-aortic balloon pump through the arterial access site
  • Cardiogenic shock during or immediately following the catheterization
  • Patient is unable to ambulate at baseline
  • Patient is known or suspected to be pregnant or is lactating
  • Patient is unavailable for follow-up
  • Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345631

Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sutter Memorial Hospital
Sacramento, California, United States, 95819
Stanford University
Stanford, California, United States, 94305-5218
United States, Florida
Morton Plant Hosptial
Clearwater, Florida, United States, 33756
United States, Indiana
The Care Group
Indianapolis, Indiana, United States, 46290
United States, Missouri
Washington University School of Medicine at Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Health Systems
Camden, New Jersey, United States, 08103
United States, New York
SJH Cardiology Associates
Liverpool, New York, United States, 13088
New York Presbyterian Hospital - Cornell Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Wake Heart Research
Raleigh, North Carolina, United States, 27610
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Hahnemann Hospital
Philadelphia, Pennsylvania, United States, 19102
Moffitt Heart & Vascular Group
Wormleysburg, Pennsylvania, United States, 17043
United States, Texas
Baylor Research Institute
Dallas, Texas, United States, 75226
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98117
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: S. Chiu Wong, MD New York Presbyterian Hospital
  More Information

Publications:
Responsible Party: Chao-Chin Chen, Vice President, Ensure Medical
ClinicalTrials.gov Identifier: NCT00345631     History of Changes
Other Study ID Numbers: EM0501
Study First Received: June 26, 2006
Results First Received: February 27, 2012
Last Updated: May 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Cordis Corporation:
Closure Device
Angiography
Angioplasty
Hemostasis
Heart Catheterization
Peripheral Angiography
Femoral Closure
Vascular Closure
Coronary Angiography

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases

ClinicalTrials.gov processed this record on August 20, 2014