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Sponsored by: |
Ensure Medical |
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Information provided by: | Ensure Medical |
ClinicalTrials.gov Identifier: | NCT00574691 |
To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
Condition | Intervention | Phase |
---|---|---|
Angioplasty, Transluminal, Percutaneous Coronary Coronary Arteriosclerosis |
Device: 7F Ensure Medical Vascular Closure Device |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial |
Enrollment: | 93 |
Study Start Date: | June 2007 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
---|---|
1
Vascular Closure Device
|
Device: 7F Ensure Medical Vascular Closure Device
Vascular Closure Device
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Multi-center (up to 6 European sites), non-blinded, non-randomized, feasibility study with a 2-month enrollment period and 30-day clinical follow-up.
60 patients (plus up to 36 "roll-in" device training patients) undergoing diagnostic or interventional coronary or peripheral procedures utilizing a 7F arterial puncture in the common femoral artery. Patients are excluded if they have a previous target artery closure with any closure device, recent myocardial infarction or thrombolytic therapy, treatment with thrombin-specific anticoagulants or low molecular weight heparin, fluoroscopically visible calcium or atherosclerosis ≤ 1 cm of puncture site, or planned target site access ≤ 30 days.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll - Director Clinical Affairs ) |
Study ID Numbers: | EM 06-01EU |
Study First Received: | December 13, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00574691 |
Health Authority: | Germany: German Institute of Medical Documentation and Information |
Closure Device Angiography Angioplasty |
Hemostasis Heart Catheterization Coronary Angiography |
Arterial Occlusive Diseases Coronary Disease Methamphetamine Heart Diseases Myocardial Ischemia |
Vascular Diseases Amphetamine Ischemia Arteriosclerosis Coronary Artery Disease |
Cardiovascular Diseases |