Radial Angiography Clinical Trial
Official title:
Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath
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.
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)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic