Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

Completed · Phase 3

Conditions studied: Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis, Peripheral Arteriosclerosis

In brief

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.

Key facts

Study ID

NCT00345631

Run by

Cordis US Corp.

People needed

488

Starts

2007-02-01

Expected to finish

2007-09-01

Last updated by the study team

2012-06-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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
• 6F 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
• 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

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• University of California Davis Medical Center — Sacramento, California, United States
• 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
• Wake Heart Research — Raleigh, North Carolina, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Hahnemann Hospital — Philadelphia, Pennsylvania, United States
• Moffitt Heart & Vascular Group — Wormleysburg, Pennsylvania, United States
• Baylor Research Institute — Dallas, Texas, United States
• LDS Hospital — Salt Lake City, Utah, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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