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

Not Applicable

Completed

• Conditions: Stable Coronary Heart Disease
• Interventions: Device: One-catheter concept; Device: Standard catheter

• Registration Number: NCT02947542
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2016-11
• Study Completion: 2016-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-14
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tiger catheter	One-catheter concept	Coronary angiography will be performed with the Tiger catheter (one-catheter concept).
BLK catheter	One-catheter concept	Coronary angiography will be performed with the BLK catheter (one-catheter concept).
Judkins catheter	Standard catheter	Coronary angiography will be performed with the Judkins catheter (standard catheter).

Primary Outcome Measures

Name	Time	Method
Coronary angiography Duration (sec)	Day 0 (corresponding to time point of procedure)	assessed by Intention-to-treat analysis (IIT)

Secondary Outcome Measures

Name	Time	Method
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)
Cross over rate to another catheter or transfemoral access.	Day 0 (corresponding to time point of procedure)
Contrast volume (ml)	Day 0 (corresponding to time point of procedure)
Flouroscopy time (sec)	Day 0 (corresponding to time point of procedure)

Trial Locations

Locations (1)

Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany