Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr S Rathore


Contact details

Department of Cardiology
The Cardiothoracic Centre
Thomas Drive
L14 3PE
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

Radial artery spasm is a common complication and several small studies have shown conflicting results with the use of different spasmolytic cocktails prior to transradial access.

Several different length sheaths are used by radial operators and there are no studies done so far to compare different sheaths and their effects on access site outcomes and impact on radial artery physiology. Some radial operators routinely use different spasmolytic cocktail prior to transradial procedures with no studies so far convincingly supporting this action.

Several different post procedure haemostatic techniques have been used ranging from tourniquets, compression devices and hydrophilic wound dressings. Various haemostatic compression devices specific to radial artery are marketed and Radistop [RADI Medical Systems B] and TR Band [Terumo] are widely used. There are no comparative studies done between these compression devices on outcomes and patient tolerance.
Recently there have been reports of sterile inflammatory abscesses with the usage of sheaths with hydrophilic coatings. These inflammatory reactions are reported in 2-3% of cases [39-41].

The ramifications of radial artery occlusion and injury are important not only in patients undergoing repeat interventional procedures, but also in patients in whom the radial artery may be used as a conduit for coronary artery bypass surgery or in patients needing arterio venous fistula for haemodialysis. Radial artery spasm is a common morbidity which can cause considerable discomfort to the patient and can prevent successful completion of procedure. To assess the impact of length and hydrophilic coating of the transradial introducer sheath on incidence of radial artery occlusion, radial artery spasm, local inflammatory reaction and other vascular complications.

To compare the impact of the TR band and Radistop compression haemostatic devices on the time taken to achieve haemostasis, radial artery occlusion rates, local vascular complications and patients tolerance of the device.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised single blinded single centre study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Surgery: Thoracic


We will invite and screen all patients considered for coronary catheterisation and coronary intervention by the transradial approach.

Patients will be allocated in random fashion to different treatment strategies.
Method of randomisation: simple randomisation by opening an envelope just before procedure in catheterisation laboratory. Continuous variables will be described as mean +/- SD and compared using Student’s t test. Categorical variables will be expressed as frequencies and compared by chi-square statistics.
Multivariate analysis will be performed to identify the predictors of radial artery spasm and radial artery occlusion.

This will be a prospective, randomised, single blinded, single centre study. Patients will be randomised in factorial design as follows:

1:1:1:1 Randomisation to following sheaths:

- Long [23 cm] hydrophilic coated sheath
- Long [23 cm] uncoated sheath
- Short [13 cm] hydrophilic coated sheath
- Short [13 cm] uncoated sheath

1:1 Randomisation to following compression devices to achieve haemostasis at the end of procedure

- TR band vs Radistop compression device

Intervention type



Not Specified

Drug names

Primary outcome measures

Primary end points: Incidence of clinical radial artery spasm.

Secondary outcome measures

1. Incidence of radial artery occlusion rates
2. Incidence of local vascular complications
3. Incidence of sterile inflammatory reaction
4. Incidence of spontaneous recanalisation of radial artery
5. Time to achieve haemostasis
6. Patient tolerance of haemostatic deviceThis study will help us in defining the problem of radial artery spasm, radial artery occlusion and local vascular complications.

This study results will help us in deciding the best sheath and compression device from the variety of products available commercially for transradial coronary procedures.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Sample size - Clinical radial artery spasm rates are reported between 20-30% [as per literature] and to detect 50% reduction in incidence of radial artery spasm, we need to recruit 175 [200] patients in each arm. This is with significance level of 0.05 [alpha error], and power of 80% [beta error- .02]. In total we need 800 patients with 200 patients in each arm of different sheath type. There will therefore be 400 patients in each arm of compression device randomisation [TR band vs. Radistop].

Target population - All patients considered for coronary angiography and coronary intervention by the transradial approach. Inclusion Criteria:
1. Intended transradial coronary procedure
2. Patient > 18 years of age and able to give informed consent.

All patients undergoing transradial procedure at the Cardiothoracic Centre, Liverpool under the care of JLM, RHS, RAP, NDP [after taking their permission] will be contacted about the study and procedures will be explained. Willing patients will then be assessed in detail and informed consent will be obtained.

Participant type


Age group



Not Specified

Target number of participants


Participant exclusion criteria

1. Unable or unwilling to give informed consent
2. Inability to demonstrate the presence of ulnar collateral circulation
3. Patients with A-V fistula or patients with chronic renal failure
4. Previous ipsilateral transradial procedure

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiology
L14 3PE
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

The Cardiothoracic Centre Liverpool NHS Trust (UK) - NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in

Publication citations

  1. Results

    Rathore S, Stables RH, Pauriah M, Hakeem A, Mills JD, Palmer ND, Perry RA, Morris JL, Impact of length and hydrophilic coating of the introducer sheath on radial artery spasm during transradial coronary intervention: a randomized study., JACC Cardiovasc Interv, 2010, 3, 5, 475-483, doi: 10.1016/j.jcin.2010.03.009.

Additional files

Editorial Notes