Prevention of intimal injury during transradial coronary interventio
Completed
- Conditions
- vascular damageVascular injury1001108210047079
- Registration Number
- NL-OMON44272
- Lead Sponsor
- Haaglanden Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The occurrence of acute radial injury, detected by post-procedural radial OCT.<br /><br>-Intimal tears<br /><br>-Medial dissections<br /><br>-Intraluminal thrombi<br /><br>-Intramural hematomas.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Procedural progress:<br /><br><br /><br>-procedural time until radial OCT<br /><br>-fluoroscopy time until radial OCT<br /><br>-cross-over to contralateral radial artery or femoral artery<br /><br>-use of contrast<br /><br><br /><br>Patient*s comfort<br /><br><br /><br>1) The occurrence of radial artery spasm.<br /><br>2) Difference in pain score (Visual Analogue Scale, VAS) during and after the<br /><br>procedure.<br /><br>3) Difference in Quick DASH score (see appendix 2) before and 1 month after<br /><br>intervention<br /><br>4) Difference in CISS score (see appendix 3) before and 1 month after<br /><br>intervention<br /><br><br /><br>The occurrence of radial artery occlusion (RAO) assessed by manual palpation.<br /><br>In absence of radial artery pulse, vascular ultrasound according to the local<br /><br>protocol will be performed to confirm RAO.</p><br>