Clinical trial NCT02637843: Randomized Comparison of Sheaths for Radial Access
Official title: Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radial Angiography
Keywords: radial
angiography
angioplasty
randomized
sheath
slender
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Pain during sheath insertion
timeFrame: 1-2 minutes during sheath insertion
measure: Pain during the procedure
timeFrame: 10 minutes to 2 hours (during CAG/PCI)
measure: Proportion converted to femoral access
timeFrame: 10 minutes to 2 hours (during CAG/PCI)
measure: Use of analgesics, sedatives and verapamil during the procedure
timeFrame: 10 minutes to 2 hours (during CAG/PCI)
measure: Patency of a.radialis
timeFrame: Within one month of CAG/PCI
Secondary outcomes:
measure: Number of catheters used
timeFrame: 10 minutes to 2 hours (during CAG/PCI)
measure: Number of sheaths used
timeFrame: 10 minutes to 2 hours (during CAG/PCI)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of cardiology, Aarhus University Hospital in Skejby
Study officials:
References: