Systematic Assessment of the Cook Radial shEath Device

ISRCTN ISRCTN51223303
DOI https://doi.org/10.1186/ISRCTN51223303
Secondary identifying numbers 801
Submission date
05/10/2013
Registration date
17/10/2013
Last edited
12/12/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Coronary angiograms are performed to examine the condition of the arteries that supply blood to the heart muscle. Coronary angioplasty involves the widening of the heart arteries with a balloon, often followed by the placement of a metal mesh-like structure called a stent. Traditionally these have been performed by passing a narrow tube called a catheter through a sheath inserted into an artery in the groin called the femoral artery. There has been a rapidly growing trend to perform these procedures through an artery in the wrist called the radial artery. The radial route has the advantage of lower complications and patients are often able to move earlier following their procedures. The radial artery however is smaller than the femoral, it is also more muscular and prone to spasm. To help prevent this, radial sheaths can be coated with a slippery substance. In the past a small number of patients have reported a skin reaction at the puncture site (thought to be from this coating), a couple of weeks or so after their procedure. The manufacturers of the sheath have made changes to their product. The aim of this is to eliminate or reduce the chance of this reaction occurring. Subsequently the study team would now like to follow the patients after their procedure to confirm that their skin puncture heals satisfactorily. Other routine information about the performance of the sheath will also be collected such as whether the procedure could be completed as planned.

Who can participate?
Patients aged over 18 admitted to the study hospital for a planned radial coronary procedure

What does the study involve?
Participants undergo their procedure as normal. Before they go home, a member of the study team provides them with some additional and contact information. If they experience any problems with their puncture site, they are encouraged to contact the study team. If they do not experience a problem they are contacted at around 28 days to confirm the absence of problems.

What are the possible risks and benefits of participating?
There are no direct benefits to participants. Personal results are not used in any way without their permission. The overall anonymous group results of the study may be directly used to inform the manufacturer of the optimal design of their product. There are no additional risks in taking part in the study. The risks are the same as those explained by the doctor when they were asked to consent for the procedure.

Where is the study run from?
Liverpool Heart and Chest Hospital NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2013 to April 2014

Who is funding the study?
Cook Medical (USA)

Who is the main contact for the study?
1. Mrs Christine Mars
Christine.Mars@lhch.nhs.uk
2. Dr Rod Stables
Rod.Stables@lhch.nhs.uk

Contact information

Mrs Christine Mars
Scientific

Research Nurse
Liverpool Heart and Chest Hospital NHS Foundation Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom

Phone +44 (0)151 600 1158
Email Christine.Mars@lhch.nhs.uk

Study information

Study designObservational prospective single-centre registry study
Primary study designObservational
Secondary study designSingle-centre
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleA prospective, single centre registry study recruiting consecutive patients to examine the safety, efficacy and subsequent incidence of cutaneous reaction with use of the Cook Flexor Radial Introducer Set
Study acronymSACRED
Study objectivesObservational study to describe the incidence of granuloma reactions observed after use of the study sheath device for radial access for coronary diagnostic and interventional procedures.
Ethics approval(s)National Research Ethics Service (NRES) Committee North West - Liverpool Central; 12/01/2010; ref: 09/H1005/72
Health condition(s) or problem(s) studiedCutaneous granuloma formation following the use of radial introducer sheaths used in coronary angiography and angioplasty procedures
InterventionPatients will be provided with some additional information prior to discharge. What they might expect with normal healing will be explained to them. Patients will be encouraged to contact the study team via email or dedicated phone line with voice messaging facilities. Such patients will be invited to return to the study centre for clinical review to allow formal assessment of the puncture site for the primary outcome measure. All other patients will be contacted by telephone, text or email at 28 days (+ 7 days) to confirm the absence of problems. Patients will equivocal responses will be invited for clinical assessment.

It is important to note that the sheath being studied is currently in use in all patients undergoing coronary angiography or angioplasty via the radial artery at the study centre. In participating in the study, patients are not being asked to trial a new or different sheath from any other patient.
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureThe incidence of granuloma formation by 28 days defined as an indurated, erythematous lesion, at least 3mm in its longest diameter, not related to haematoma
Secondary outcome measures1. The rate of successful insertion of the study sheath device
2. The rate of successful completion of the coronary procedure through the initial sheath device
3. The incidence of administration of intra-arterial vasodilator agents for the management of coronary artery spasm (routine administration is not practice at the study centre)

The rate of other vascular complications
1. Small haematoma ≤ 3cm diameter
2. Large haematoma > 3cm diameter
3. The incidence of blood transfusion related to access site complications
4. The incidence of surgical or other interventional procedures for the management of vascular access complications
5. Delayed discharge necessitating an unplanned night or more in hospital related to vascular access complications

All secondary outcome measures are recorded following the index procedure and prior to hospital discharge.
Overall study start date09/10/2013
Completion date30/04/2014

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants415 including 2-3% failure rate
Key inclusion criteria1. Patients admitted for cardiac procedures with planned radial access
2. Patients under the care of a participating consultant
Key exclusion criteria1. Patients under 18 years of age
2. Patients unable to give informed consent
3. Patients who feel unable or unwilling to return to the study centre for outcome measure assessment
4. Patients who have had previous procedures through the same radial access site
5. Emergency or high risk procedures with survival doubt
6. Where there is a known sensitivity to the study device
Date of first enrolment09/10/2013
Date of final enrolment06/03/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool
L14 3PE
United Kingdom

Sponsor information

Liverpool Heart and Chest Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Dr Margarita Perez-Casal
Thomas Drive
Liverpool
L14 3PE
England
United Kingdom

Phone +44 (0)151 600 1616
Email Margarita.Perez-Casal@lhch.nhs.uk
Website http://www.lhch.nhs.uk
ROR logo "ROR" https://ror.org/000849h34

Funders

Funder type

Industry

Cook Medical
Private sector organisation / For-profit companies (industry)
Alternative name(s)
COOK MEDICAL LLC, Cook
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

12/12/2017: No publications found, verifying study status with principal investigator.