Randomized Comparison of Sheaths for Radial Access

Study Overview
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Brief Summary
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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
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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: Use of Slender sheath results in less pain related to CAG/PCI compared to use of Standard sheath. Use of Slender sheath is associated with fewer conversions to femoral access compared to use of Standard sheath. Use of Slender sheath is associated with less use of analgesic during the procedure compared to use of Standard sheath. 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 Pain related to the application of the sheath (Visual Analog Scale = VAS) Maximal pain during CAG/PCI (VAS) Frequency of conversions to femoral access Use of analgesics (cumulative amount of mg Fentanyl given) Use of sedatives (cumulative amount of mg Midazolam given) Use of Verapamil (cumulative amount of mg given, used to reduce spasms) Number of catheters used Number of sheaths used (femoral and radial) Occlusion of a. radialis at the time of discharge estimated by ultrasound of the artery 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)

Official Title
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Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath

Conditions
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Radial Angiography

Intervention / Treatment
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* Device: Slender Sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients scheduled for radial angiography or angioplasty Able to give written informed consent Exclusion Criteria: Negative Barbaue test or Allens test Use of 8F catheters

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Slender arm<br>Uses the terumo slender sheath for radial angiography or angioplasty | Device: Slender Sheath<br>* Comparing outcomes for two different sheaths used during radial CAG/PCI<br>|
| No Intervention: Standard arm<br>Uses the terumo standard sheath (Routine) for radial angiography or angioplasty | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 10 minutes to 2 hours (during CAG/PCI) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial, angiography, angioplasty, randomized, sheath, slender