Stable Coronary Heart Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEOne-catheter concept
Coronary angiography will be performed using the one-catheter concept.
DEVICEStandard catheter
Coronary angiography will be performed using a standard catheter.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and ≤ 95 years * Body weight \> 60kg
Exclusion criteria
* Acute coronary syndrome or cardiogenic shock * Contraindications for transracial access such as absence of radial pulse or abnormal Allen test * Prior unsuccessful transradial coronary angiography * Estimated glomerular filtration rate \<40 ml/kg/min * Patients not able to give informed consent * Participation in another trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary angiography Duration (sec) | Day 0 (corresponding to time point of procedure) | assessed by Intention-to-treat analysis (IIT) |
Secondary
| Measure | Time frame |
|---|---|
| Cross over rate to another catheter or transfemoral access. | Day 0 (corresponding to time point of procedure) |
| Flouroscopy time (sec) | Day 0 (corresponding to time point of procedure) |
| Contrast volume (ml) | Day 0 (corresponding to time point of procedure) |
| Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications). | Day 0 (corresponding to time point of procedure) |
| Imaging Quality (ostial stability, diagnostic value) | Day 0 (corresponding to time point of procedure) |
Countries
Germany
Outcome results
None listed