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Prevention of intimal injury during transradial coronary intervention

Prevention of intimal injury during transradial coronary intervention - Railway Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44272
Enrollment
50
Registered
2017-10-06
Start date
2018-01-18
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

vascular damage Vascular injury

Interventions

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.

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: -Severe renal dysfunction (eGFR

Design outcomes

Primary

MeasureTime frame
The occurrence of acute radial injury, detected by post-procedural radial OCT. -Intimal tears -Medial dissections -Intraluminal thrombi -Intramural hematomas.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)