Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slender arm | Active Comparator | Uses the terumo slender sheath for radial angiography or angioplasty |
|
| Standard arm | No Intervention | Uses the terumo standard sheath (Routine) for radial angiography or angioplasty |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Slender Sheath | Device | Comparing outcomes for two different sheaths used during radial CAG/PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain during sheath insertion | Maximal pain (Visual analogue scale) during sheath insertion | 1-2 minutes during sheath insertion |
| Pain during the procedure | Maximal pain (Visual analogue scale) during CAG/PCI | 10 minutes to 2 hours (during CAG/PCI) |
| Proportion converted to femoral access | Proportion of patients where the operator has to change to femoral access to complete the CAG/PCI | 10 minutes to 2 hours (during CAG/PCI) |
| Use of analgesics, sedatives and verapamil during the procedure | cumulative amount of analgesics, sedatives and verapamil during the procedure | 10 minutes to 2 hours (during CAG/PCI) |
| Patency of a.radialis | Ultrasound and reverse Barbaeu test is performed to test patency of a.radialis following CAG/PCI. If patency not documented at time of discharge the tests are repeated at one month. The artery is patent if normal Barbaue test and ultrasound without occlusion. | Within one month of CAG/PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Number of catheters used | cumulative number of catheters used during the procedure | 10 minutes to 2 hours (during CAG/PCI) |
| Number of sheaths used | cumulative number of sheaths used during the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiology, Aarhus University Hospital in Skejby | Aarhus | 8200 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 10 minutes to 2 hours (during CAG/PCI) |