NCT01625533

Safety and Efficacy Study of Dual-axis Rotational Versus Standard Coronary Angiography

Randomized Study on the Safety and Efficacy of Dual-axis Rotational Versus Standard Coronary Angiography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 576 (actual)
• Sponsor: General Hospital of Chinese Armed Police Forces · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the clinical safety and efficacy of dual-axis rotational coronary angiography (DARCA) in the diagnosis of coronary artery disease by directly comparing it to standard coronary angiography (SA).

Detailed description

Dual-axis rotational coronary angiography (DARCA) was developed as an innovative adaptation of rotational angiography (RA), but it requires a longer coronary injection compared to standard coronary angiography (SA). The risk of complications from the contrast agent (such as discomfort, warmth, pain, hypotension and bradycardia) is increased with the use of DARCA. It remains to be evaluated whether this approach is also suitable for coronary angiography, especially using in the patients with complex coronary lesions. Previous studies revealed promising results, but the number of patients included did not provide sufficient statistical power to allow a valid comparison of DARCA with SA. The purpose of this study is to evaluate the feasibility, safety, clinical tolerance, and hemodynamic effect of DARCA in comparison to the well-established SA.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Standard Coronary Angiography	Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.
PROCEDURE	Dual-axis Rotational Coronary Angiography	Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-06-21
• Last updated: 2015-06-08

Locations

1 site across 1 country: China