Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
ECLIPSE Trial - Ensure's Vascular Closure Device Speeds Hemostasis Trial
1 other identifier
interventional
488
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2007
Shorter than P25 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2006
CompletedFirst Posted
Study publicly available on registry
June 28, 2006
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedResults Posted
Study results publicly available
March 19, 2012
CompletedJune 1, 2012
May 1, 2012
June 26, 2006
February 27, 2012
May 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
From post-procedure to 30 days follow up
Secondary Outcomes (6)
Time to Eligibility for Hospital Discharge
From introducer sheath removal to hospital discharge, up to 284 hours
Time to Hospital Discharge
From introducer sheath removal to patient discharge
Time to Device Deployment, up to 5 Minutes
From device inserted to introducer sheath removal
Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure
Within 5 minutes post-procedure
Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure
From catheterization procedure to 30 day post-procedure follow up
- +1 more secondary outcomes
Study Arms (2)
Manual Compression
ACTIVE COMPARATORManual compression (MC)
Vascular Closure Device
EXPERIMENTALVascular Closure Device (VCD)
Interventions
Investigational vascular closure device
Eligibility Criteria
You may qualify if:
- Scheduled for a coronary or peripheral diagnostic or interventional procedure
- Able to undergo emergent vascular surgery if a complication requires it
- F arterial puncture located in the common femoral artery
- Femoral artery has a lumen diameter of at least 5 mm
You may not qualify if:
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cordis US Corp.lead
Study Sites (17)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Sutter Memorial Hospital
Sacramento, California, 95819, United States
Stanford University
Stanford, California, 94305-5218, United States
Morton Plant Hosptial
Clearwater, Florida, 33756, United States
The Care Group
Indianapolis, Indiana, 46290, United States
Washington University School of Medicine at Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Cooper Health Systems
Camden, New Jersey, 08103, United States
SJH Cardiology Associates
Liverpool, New York, 13088, United States
New York Presbyterian Hospital - Cornell Medical College of Cornell University
New York, New York, 10021, United States
Wake Heart Research
Raleigh, North Carolina, 27610, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44122, United States
Hahnemann Hospital
Philadelphia, Pennsylvania, 19102, United States
Moffitt Heart & Vascular Group
Wormleysburg, Pennsylvania, 17043, United States
Baylor Research Institute
Dallas, Texas, 75226, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Swedish Medical Center
Seattle, Washington, 98117, United States
Related Publications (1)
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. doi: 10.1016/j.jcin.2009.06.006.
PMID: 19695549RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hans-Peter Stoll, M.D.
- Organization
- Cordis Corporation, a Johnson&Johnson company
Study Officials
- PRINCIPAL INVESTIGATOR
S. Chiu Wong, MD
New York Presbyterian Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 26, 2006
First Posted
June 28, 2006
Study Start
February 1, 2007
Study Completion
September 1, 2007
Last Updated
June 1, 2012
Results First Posted
March 19, 2012
Record last verified: 2012-05