Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial

Conditions
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Stable Coronary Heart Disease

Intervention / Treatment
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* Device: One-catheter concept
* Device: Standard catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLK catheter<br>Coronary angiography will be performed with the BLK catheter (one-catheter concept). | Device: One-catheter concept<br>* Coronary angiography will be performed using the one-catheter concept.<br>|
| Experimental: Tiger catheter<br>Coronary angiography will be performed with the Tiger catheter (one-catheter concept). | Device: One-catheter concept<br>* Coronary angiography will be performed using the one-catheter concept.<br>|
| Active Comparator: Judkins catheter<br>Coronary angiography will be performed with the Judkins catheter (standard catheter). | Device: Standard catheter<br>* Coronary angiography will be performed using a standard catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary angiography Duration (sec) | assessed by Intention-to-treat analysis (IIT) | Day 0 (corresponding to time point of procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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) |