Completed

NCT Number: NCT02637843

Randomized Comparison of Sheaths for Radial Access

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radial Angiography

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, 8200, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slender Sheath

Device

Comparing outcomes for two different sheaths used during radial CAG/PCI

Primary outcomes

Pain during sheath insertion

Time frame: 1-2 minutes during sheath insertion

Maximal pain (Visual analogue scale) during sheath insertion
Pain during the procedure

Time frame: 10 minutes to 2 hours (during CAG/PCI)

Maximal pain (Visual analogue scale) during CAG/PCI
Proportion converted to femoral access

Time frame: 10 minutes to 2 hours (during CAG/PCI)

Proportion of patients where the operator has to change to femoral access to complete the CAG/PCI
Use of analgesics, sedatives and verapamil during the procedure

Time frame: 10 minutes to 2 hours (during CAG/PCI)

cumulative amount of analgesics, sedatives and verapamil during the procedure
Patency of a.radialis

Time frame: Within one month of CAG/PCI

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.

Secondary outcomes

Number of catheters used

Time frame: 10 minutes to 2 hours (during CAG/PCI)

cumulative number of catheters used during the procedure
Number of sheaths used

Time frame: 10 minutes to 2 hours (during CAG/PCI)

cumulative number of sheaths used during the procedure

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath

Acronym: ACCESS-I

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Dec 22, 2015
Registry last updated: Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.