Clinical trial NCT02947542: Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
Official title: Use of Different Diagnostic Coronary Catheters Over the Radial Access - the UDDC - Radial Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stable Coronary Heart Disease
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Coronary angiography Duration (sec)
timeFrame: Day 0 (corresponding to time point of procedure)
Secondary outcomes:
measure: Cross over rate to another catheter or transfemoral access.
timeFrame: Day 0 (corresponding to time point of procedure)
measure: Flouroscopy time (sec)
timeFrame: Day 0 (corresponding to time point of procedure)
measure: Contrast volume (ml)
timeFrame: Day 0 (corresponding to time point of procedure)
measure: Safety endpoints (kinking, radial spasm, vascular access complications, bleeding complications).
timeFrame: Day 0 (corresponding to time point of procedure)
measure: Imaging Quality (ostial stability, diagnostic value)
timeFrame: Day 0 (corresponding to time point of procedure)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Department of Cardiology, Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
name: David M Leistner, PD
role: PRINCIPAL_INVESTIGATOR
References: