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

Primary Purpose

Stable Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
One-catheter concept
Standard catheter
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stable Coronary Heart Disease

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

BLK catheter

Tiger catheter

Judkins catheter

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Coronary angiography Duration (sec)
assessed by Intention-to-treat analysis (IIT)

Secondary Outcome Measures

Cross over rate to another catheter or transfemoral access.
Flouroscopy time (sec)
Contrast volume (ml)
Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
Imaging Quality (ostial stability, diagnostic value)

Full Information

First Posted
October 18, 2016
Last Updated
May 14, 2017
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02947542
Brief Title
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
Acronym
UDDC
Official Title
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Heart Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BLK catheter
Arm Type
Experimental
Arm Description
Coronary angiography will be performed with the BLK catheter (one-catheter concept).
Arm Title
Tiger catheter
Arm Type
Experimental
Arm Description
Coronary angiography will be performed with the Tiger catheter (one-catheter concept).
Arm Title
Judkins catheter
Arm Type
Active Comparator
Arm Description
Coronary angiography will be performed with the Judkins catheter (standard catheter).
Intervention Type
Device
Intervention Name(s)
One-catheter concept
Intervention Description
Coronary angiography will be performed using the one-catheter concept.
Intervention Type
Device
Intervention Name(s)
Standard catheter
Intervention Description
Coronary angiography will be performed using a standard catheter.
Primary Outcome Measure Information:
Title
Coronary angiography Duration (sec)
Description
assessed by Intention-to-treat analysis (IIT)
Time Frame
Day 0 (corresponding to time point of procedure)
Secondary Outcome Measure Information:
Title
Cross over rate to another catheter or transfemoral access.
Time Frame
Day 0 (corresponding to time point of procedure)
Title
Flouroscopy time (sec)
Time Frame
Day 0 (corresponding to time point of procedure)
Title
Contrast volume (ml)
Time Frame
Day 0 (corresponding to time point of procedure)
Title
Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
Time Frame
Day 0 (corresponding to time point of procedure)
Title
Imaging Quality (ostial stability, diagnostic value)
Time Frame
Day 0 (corresponding to time point of procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Leistner, PD
Organizational Affiliation
Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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