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More info
You can access this
clinical trial
if you have
Radial Angiography
and you are
between 18 and 100
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Device: Slender Sheath

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02637843. The sponsor of the trial is Aarhus University Hospital Skejby and it is looking for 1000 volunteers for the current phase.
Official trial title:
Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath