Systematic Assessment of the Cook Radial shEath Device

A 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN51223303

Enrollment

415

Registered

2013-10-17

Start date

2013-10-09

Completion date

Unknown

Last updated

2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous granuloma formation following the use of radial introducer sheaths used in coronary angiography and angioplasty procedures Circulatory System

Interventions

Patients 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 te

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients admitted for cardiac procedures with planned radial access 2. Patients under the care of a participating consultant

Exclusion criteria

Exclusion criteria: 1. 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

Design outcomes

Primary

Measure	Time frame
The 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

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026