There is no evidence from prospective randomized clinical trials regarding the performance of conventional (two-catheter-concept; TCC) versus one-catheter-concepts (OCC) for invasive coronary angiography over the radial access. The aim of the present trial is to evaluate the efficacy and safety of different one-catheter concepts by use of the BLK and Tiger catheter compared to a TCC using standard Judkins catheters in diagnostic coronary angiography via transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK or Tiger (OCC) or Judkins catheters (TCC). The primary endpoint is coronary angiography duration.
The aim of the present trial is to evaluate the efficacy and safety of a one-catheter concept using the BLK (Terumo, Somerset, USA) or the Tiger catheter (Terumo, Somerset, USA) compared to the standard Judkins catheters in diagnostic coronary angiography by the transradial access. Patients with stable angina pectoris will be randomly assigned to coronary angiography performed with the BLK (Group I), Tiger (Group II) or Judkins catheters (Group III). Primary endpoint is the time duration (sec) that is necessary to perform complete coronary angiography including 6 different projections for the left-coronary system and 3 different projections of the right-coronary-system. Secondary endpoints will cover safety and imaging quality of the different catheter systems.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
300
Coronary angiography will be performed using the one-catheter concept.
Coronary angiography will be performed using a standard catheter.
Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Berlin, Germany
Coronary angiography Duration (sec)
assessed by Intention-to-treat analysis (IIT)
Time frame: Day 0 (corresponding to time point of procedure)
Cross over rate to another catheter or transfemoral access.
Time frame: Day 0 (corresponding to time point of procedure)
Flouroscopy time (sec)
Time frame: Day 0 (corresponding to time point of procedure)
Contrast volume (ml)
Time frame: Day 0 (corresponding to time point of procedure)
Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
Time frame: Day 0 (corresponding to time point of procedure)
Imaging Quality (ostial stability, diagnostic value)
Time frame: Day 0 (corresponding to time point of procedure)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.