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NCT Number: NCT02947542

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

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.

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Key information

Conditions

Stable Coronary Heart Disease

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One-catheter concept

Device

Coronary angiography will be performed using the one-catheter concept.

Standard catheter

Device

Coronary angiography will be performed using a standard catheter.

Primary outcomes

  1. Coronary angiography Duration (sec)

    Time frame: Day 0 (corresponding to time point of procedure)

    assessed by Intention-to-treat analysis (IIT)

Secondary outcomes

  1. Cross over rate to another catheter or transfemoral access.

    Time frame: Day 0 (corresponding to time point of procedure)

  2. Flouroscopy time (sec)

    Time frame: Day 0 (corresponding to time point of procedure)

  3. Contrast volume (ml)

    Time frame: Day 0 (corresponding to time point of procedure)

  4. Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).

    Time frame: Day 0 (corresponding to time point of procedure)

  5. Imaging Quality (ostial stability, diagnostic value)

    Time frame: Day 0 (corresponding to time point of procedure)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: UDDC

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2016
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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