Radial Angiography Clinical Trial
— ACCESS-IOfficial title:
Randomized Comparison of Coated Slender Versus Un-coated Traditional Sheath
| Verified date | August 2016 |
| Source | Aarhus University Hospital Skejby |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 100 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of cardiology, Aarhus University Hospital in Skejby | Aarhus |
| Lead Sponsor | Collaborator |
|---|---|
| Aarhus University Hospital Skejby |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain during sheath insertion | Maximal pain (Visual analogue scale) during sheath insertion | 1-2 minutes during sheath insertion | Yes |
| Primary | Pain during the procedure | Maximal pain (Visual analogue scale) during CAG/PCI | 10 minutes to 2 hours (during CAG/PCI) | Yes |
| Primary | 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) | No |
| Primary | 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) | Yes |
| Primary | 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 | Yes |
| Secondary | Number of catheters used | cumulative number of catheters used during the procedure | 10 minutes to 2 hours (during CAG/PCI) | No |
| Secondary | Number of sheaths used | cumulative number of sheaths used during the procedure | 10 minutes to 2 hours (during CAG/PCI) | No |