Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
Condition: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Arteriosclerosis; Peripheral Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Intervention: Manual Compression; Vascular Closure Device
Intervention description: Manual compression; Investigational vascular closure device
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 488.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Closure Device; Angiography; Angioplasty; Hemostasis; Heart Catheterization; Peripheral Angiography; Femoral Closure; Vascular Closure; Coronary Angiography

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.
    

Eligibility 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/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