Status:
COMPLETED
Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
Lead Sponsor:
Cordis US Corp.
Conditions:
Angioplasty, Transluminal, Percutaneous Coronary
Coronary Arteriosclerosis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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 follo...
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. He...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT00345631
Start Date
February 1 2007
End Date
September 1 2007
Last Update
June 1 2012
Active Locations (17)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
University of California Davis Medical Center
Sacramento, California, United States, 95817
3
Sutter Memorial Hospital
Sacramento, California, United States, 95819
4
Stanford University
Stanford, California, United States, 94305-5218