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

May 14, 2017 updated by: David Manuel Leistner, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Cross over rate to another catheter or transfemoral access.
Time Frame: Day 0 (corresponding to time point of procedure)
Day 0 (corresponding to time point of procedure)
Flouroscopy time (sec)
Time Frame: Day 0 (corresponding to time point of procedure)
Day 0 (corresponding to time point of procedure)
Contrast volume (ml)
Time Frame: Day 0 (corresponding to time point of procedure)
Day 0 (corresponding to time point of procedure)
Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
Time Frame: Day 0 (corresponding to time point of procedure)
Day 0 (corresponding to time point of procedure)
Imaging Quality (ostial stability, diagnostic value)
Time Frame: Day 0 (corresponding to time point of procedure)
Day 0 (corresponding to time point of procedure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: David M Leistner, PD, Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2017

Last Update Submitted That Met QC Criteria

May 14, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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