Randomized Comparison of Sheaths for Radial Access

NCT ID: NCT02637843

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-07-31

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)

Conditions

Radial Angiography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Slender arm

Uses the terumo slender sheath for radial angiography or angioplasty

Group Type: ACTIVE_COMPARATOR

Slender Sheath

Intervention Type: DEVICE

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

Standard arm

Uses the terumo standard sheath (Routine) for radial angiography or angioplasty

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Slender Sheath

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Christian Juhl Terkelsen

MD, DmSc, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

ACCESS-I

Identifier Type: -

Identifier Source: org_study_id