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

Charité University Medicine Berlin

Status: Completed

Conditions: Stable Coronary Heart Disease

Treatments: Device: Standard catheter; Device: One-catheter concept

Study type: Interventional

Funder types: Other

Identifiers

NCT02947542

1.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

BLK catheter

Experimental group

Description:

Coronary angiography will be performed with the BLK catheter (one-catheter concept).

Treatment:

Device: One-catheter concept

Tiger catheter

Experimental group

Description:

Coronary angiography will be performed with the Tiger catheter (one-catheter concept).

Treatment:

Device: One-catheter concept

Judkins catheter

Active Comparator group

Description:

Coronary angiography will be performed with the Judkins catheter (standard catheter).

Treatment:

Device: Standard catheter