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

NCT02947542 | Completed

• 1 other identifier: 1.1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stable Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Coronary angiography Duration (sec)

  assessed by Intention-to-treat analysis (IIT)

  Day 0 (corresponding to time point of procedure)

Secondary Outcomes (5)

• Cross over rate to another catheter or transfemoral access.

  Day 0 (corresponding to time point of procedure)

• Flouroscopy time (sec)

  Day 0 (corresponding to time point of procedure)

• Contrast volume (ml)

  Day 0 (corresponding to time point of procedure)

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

  Day 0 (corresponding to time point of procedure)

• Imaging Quality (ostial stability, diagnostic value)

  Day 0 (corresponding to time point of procedure)

Study Arms (3)

BLK catheter

EXPERIMENTAL

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

Device: One-catheter concept

Tiger catheter

EXPERIMENTAL

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

Device: One-catheter concept

Judkins catheter

ACTIVE COMPARATOR

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

Device: Standard catheter

Interventions

One-catheter concept DEVICE

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

BLK catheter; Tiger catheter

Standard catheter DEVICE

Coronary angiography will be performed using a standard catheter.

Judkins catheter

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and ≤ 95 years
• Body weight \> 60kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 12203, Germany

Location

Study Officials

• David M Leistner, PD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 28, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

DE (1)