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
Study type: Interventional
Phase: Phase 3

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.
    

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. Hemostasis at the femoral artery access site after diagnostic or
      interventional procedures is typically achieved using either manual compression or the
      deployment of a vascular closure device. Manual compression is time consuming for the
      health-care provider, and painful for the patient. In addition, prolonged periods of
      immobilization and bed rest may be required. Vascular closure devices have been developed to
      avoid manual compression, shorten bed rest, and allow earlier ambulation.

      The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site
      closure in patients who have undergone coronary or peripheral diagnostic or interventional
      procedure using a standard 6F introducer sheath. The device is comprised of a bio-absorbable
      plug and a plug delivery system. The plug delivery system is designed to position the
      bio-absorbable plug to the extravascular surface of the femoral artery access site,
      facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior
      feasibility trial of 149 patients, which demonstrated that: (1) the device could be used to
      successfully obtain rapid hemostasis and early ambulation in patients undergoing
      catheterization procedures; and (2) the low incidence and relatively minor nature of the
      observed closure related complications suggests that the device is safe for its intended
      purpose.

      The ECLIPSE Trial is designed to evaluate the safety and effectiveness of the Ensure Medical
      VCD in comparison to standard manual compression. Patients will be randomly assigned to have
      their arterial access site closed using either manual compression or the VCD. The principal
      comparisons of the two closure techniques will include:

        -  Time required to obtain hemostasis of the vascular access site

        -  Time required for the patient to ambulate after their catheterization

        -  Frequency of occurrence of serious closure-related complications
    

Intervention name(s): Manual Compression; Vascular Closure Device
Intervention type(s): Other; Device
Intervention description(s): Manual compression; Investigational vascular closure device
Other intervention name(s): Exoseal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closure Device; Angiography; Angioplasty; Hemostasis; Heart Catheterization; Peripheral Angiography; Femoral Closure; Vascular Closure; Coronary Angiography