To prevent vessel damage of the radial artery by using the Cordis Railway sheathless guiding catheter system.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of acute radial injury, detected by post-procedural radial OCT.
-Intimal tears
-Medial dissections
-Intraluminal thrombi
-Intramural hematomas.
Secondary outcome
Procedural progress:
-procedural time until radial OCT
-fluoroscopy time until radial OCT
-cross-over to contralateral radial artery or femoral artery
-use of contrast
Patient*s comfort
1) The occurrence of radial artery spasm.
2) Difference in pain score (Visual Analogue Scale, VAS) during and after the
procedure.
3) Difference in Quick DASH score (see appendix 2) before and 1 month after
intervention
4) Difference in CISS score (see appendix 3) before and 1 month after
intervention
The occurrence of radial artery occlusion (RAO) assessed by manual palpation.
In absence of radial artery pulse, vascular ultrasound according to the local
protocol will be performed to confirm RAO.
Background summary
Nowadays, the radial artery is frequently used as an access route for coronary
intervention, given its low bleeding risks compared to transfemoral access.
However, due to its small diameter, the artery is prone to injury after
introduction of a radial sheath and passage of guiding catheters. The use of
sheathless guiding-catheter systems may reduce intima damage by its favourable
transition from wire to catheter and its smaller diameter.
Study objective
To prevent vessel damage of the radial artery by using the Cordis Railway
sheathless guiding catheter system.
Study design
PROBE design: Randomized open label trial with blinding of the primary
endpoint.
Intervention
Transradial access (TRA) to the coronary arteries without use of a arterial
sheath (sheathless procedure) is compared to conventional TRA with use of a
arterial sheath.
Study burden and risks
Patients will answer a questionnaire about hand function before the procedure.
The level of discomfort of the puncture of the artery and possible radial
arterial spasm is expected to be comparable to normal transradial procedures.
At the and of the procedure, the OCT imaging catheter is introduced in the
guiding-catheter; hereafter the guiding-catheter is removed, so no vascular
injury caused by the introduction of th imaging catheter is expected. During
imaging, the radial artery will be cleared of blood by injecting contrast dye.
This can result in involuntary contraction and sometimes pain of the
ipsilateral hand. The investigational product (Railway sheathless catheter
system) is expected to create less discomfort compared to a conventional
(sheath) system.
Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
-Admitted for transradial coronary angiography with option to ad-hoc coronary intervention
-Older than 18 years
-Able and willing to give informed consent
Exclusion criteria
-Severe renal dysfunction (eGFR < 30ml/min)
-Previous TRA through the same radial artery
-Intervention for ST elevation myocardial infarction
-Admitted for work-up valve disease (except TAVI)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62851.098.17 |
| OMON | NL-OMON28253 |