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

Stable Coronary Heart Disease Clinical Trial

— UDDC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02947542
• Other study ID #: 1.1
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: May 14, 2017
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Coronary Heart Disease

Intervention

Device:
• One-catheter concept
Coronary angiography will be performed using the one-catheter concept.
• Standard catheter
Coronary angiography will be performed using a standard catheter.

Locations

Country	Name	City	State
Germany	Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary angiography Duration (sec)	assessed by Intention-to-treat analysis (IIT)	Day 0 (corresponding to time point of procedure)
Secondary	Cross over rate to another catheter or transfemoral access.		Day 0 (corresponding to time point of procedure)
Secondary	Flouroscopy time (sec)		Day 0 (corresponding to time point of procedure)
Secondary	Contrast volume (ml)		Day 0 (corresponding to time point of procedure)
Secondary	Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).		Day 0 (corresponding to time point of procedure)
Secondary	Imaging Quality (ostial stability, diagnostic value)		Day 0 (corresponding to time point of procedure)