Randomized Comparison of Sheaths for Radial Access (ACCESS-I)

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 Overview

• Status: Completed
• Conditions: Radial Angiography
• Intervention / Treatment: Device: Slender Sheath

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)

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Department of cardiology, Aarhus University Hospital in Skejby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (Estimate): December 22, 2015

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 12, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: angiography; randomized; angioplasty; radial; sheath; slender
• Other Study ID Numbers: ACCESS-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO