Randomized Comparison of Sheaths for Radial Access
Condition: Radial Angiography
Study type: Interventional

Summary: 
      Coronary angiography (CAG) and possible angioplasty (Percutaneous Coronary Intervention =
      PCI) can be performed by access from the groin (a. femoralis), the wrist (a. radialis) or the
      elbow (a. brachialis). It is well established that there is less risk of bleeding
      complications when using a radial access. The smaller diameters of the vessels in the
      forearm, however, may result in increased risk of pain during CAG/PCI via a. radialis. This
      is associated with vascular spasm (spasm tendency). Ultimately this means that one may have
      to convert to access via a. femoralis.

      To perform a CAG/PCI, a tube (a so-called sheath) has to be inserted in a. radialis. It is
      unclear whether the design of the sheaths can reduce the spasm tendency, thus reducing pain.
      Terumo has recently introduced a new kind of sheath, so-called Terumo Glide Slender Heath
      Coated (hereafter referred to as "Slender sheath"). This sheath is partly coated, partly made
      of a thinner material. "Slender sheath" thus has an outer diameter smaller than that of the
      sheath from traditional use (Terumo Radio Focus sheath, hereafter referred to as "Standard
      sheath"), although the inner diameter (lumen) is the same in the two sheaths. In turn, the
      "Slender sheath" is more fragile and far more expensive.

      The purpose of the present study is to evaluate whether use of slender sheath compared with
      standard sheath is Associated with less pain and fewer complications following CAG/PCI.
    

Detailed description: 
      Study design: Randomized study

      Purposes: to investigate whether the use of "Slender sheath" is associated with less pain
      compared to use of "Standard Sheath" and less complications corresponding at the access site.
      Specific hypotheses:

        1. Use of "Slender sheath" results in less pain related to CAG/PCI compared to use of
           "Standard sheath".

        2. Use of "Slender sheath" is associated with fewer conversions to femoral access compared
           to use of "Standard sheath".

        3. Use of "Slender sheath" is associated with less use of analgesic during the procedure
           compared to use of "Standard sheath".

        4. Use of "Slender sheath" is associated with fewer cases of occlusion of a. radialis at
           discharge and post-examination compared to use of "Standard sheath".

      Time Schedule The trial will run from December 2015 until a total number of 1000 patients are
      included. It is expected that the data collection and publication of the results will be
      completed within a year.

      Endpoints

        1. Pain related to the application of the sheath (Visual Analog Scale = VAS)

        2. Maximal pain during CAG/PCI (VAS)

        3. Frequency of conversions to femoral access

        4. Use of analgesics (cumulative amount of mg Fentanyl given)

        5. Use of sedatives (cumulative amount of mg Midazolam given)

        6. Use of Verapamil (cumulative amount of mg given, used to reduce spasms)

        7. Number of catheters used

        8. Number of sheaths used (femoral and radial)

        9. Occlusion of a. radialis at the time of discharge estimated by ultrasound of the artery

       10. Occlusion of a. radialis after a month (Assumes that all patients with open vessels at
           discharge also have open vessels after a month. Only patients with occluded vessels at
           discharge will be offered a new ultrasound scan)
    

Intervention name(s): Slender Sheath
Intervention type(s): Device
Intervention description(s): Comparing outcomes for two different sheaths used during radial CAG/PCI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: radial; angiography; angioplasty; randomized; sheath; slender