Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device - Full Text View

Sponsored by:	Ensure Medical
Information provided by:	Ensure Medical
ClinicalTrials.gov Identifier:	NCT00345631

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: Exoseal	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Further study details as provided by Ensure Medical:

Primary Outcome Measures:

Time to hemostasis following vessel access site closure [ Time Frame: 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 [ Time Frame: through 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 randomized treatment without closure related major 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 ]

Enrollment:	401
Study Start Date:	February 2007
Study Completion Date:	September 2007

Arms	Assigned Interventions
1: Active Comparator Manual compression (SOC)	Other: Manual compression Manual compression
2: Experimental Investigational VCD	Device: Exoseal Investigational vascular closure device

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/m2
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. 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

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
New York Presbyterian Hospital - Cornell Medical College of Cornell University
New York, New York, United States, 10021
SJH Cardiology Associates
Liverpool, New York, United States, 13088
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
Moffitt Heart & Vascular Group
Wormleysburg, Pennsylvania, United States, 17043
Hahnemann Hospital
Philadelphia, Pennsylvania, United States, 19102
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

Ensure Medical

Investigators

Principal Investigator:

S. Chiu Wong, MD

New York Presbyterian Hospital

More Information

No publications provided by Ensure Medical

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Wong SC, Bachinsky W, Cambier P, Stoler R, Aji J, Rogers JH, Hermiller J, Nair R, Hutman H, Wang H; ECLIPSE Trial Investigators. A randomized comparison of a novel bioabsorbable vascular closure device versus manual compression in the achievement of hemostasis after percutaneous femoral procedures: The ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial). JACC Cardiovasc Interv. 2009 Aug;2(8):785-93.

Responsible Party:	Ensure Medical ( Chao-Chin Chen, Vice President )
Study ID Numbers:	EM0501
Study First Received:	June 26, 2006
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00345631 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ensure Medical:

Closure Device
Angiography
Angioplasty
Hemostasis
Heart Catheterization

Peripheral Angiography
Femoral Closure
Vascular Closure
Coronary Angiography

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Methamphetamine
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Amphetamine
Ischemia
Arteriosclerosis
Hemostatics
Coronary Artery Disease

Additional relevant MeSH terms:

Coronary Disease
Arterial Occlusive Diseases
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 11, 2009