Trials / Completed
CompletedNCT02947542
Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Charite University, Berlin, Germany · Academic / Other
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | One-catheter concept | Coronary angiography will be performed using the one-catheter concept. |
| DEVICE | Standard catheter | Coronary angiography will be performed using a standard catheter. |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2016-11-01
- Completion
- 2016-12-01
- First posted
- 2016-10-28
- Last updated
- 2017-05-16
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT02947542. Inclusion in this directory is not an endorsement.