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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-07-31

Brief Summary

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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).

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Detailed Description

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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

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SA group

Patients using SA for the diagnosis of coronary artery disease are assigned to the SA group.

Standard Coronary Angiography

Intervention Type PROCEDURE

Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.

DARCA group

Patients using DARCA for the diagnosis of coronary artery disease are assigned to the DARCA group.

Dual-axis Rotational Coronary Angiography

Intervention Type PROCEDURE

Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.

Interventions

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Standard Coronary Angiography

Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.

Intervention Type PROCEDURE

Dual-axis Rotational Coronary Angiography

Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.

Intervention Type PROCEDURE

Other Intervention Names

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Conventional Coronary Angiography DARA XPERSWING

Eligibility Criteria

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Inclusion Criteria

* Age \>18 years old
* A clinical indication for diagnostic coronary angiography to evaluate possible CAD

Exclusion Criteria

* Pregnancy
* Known allergy to iodinated contrast
* Renal insufficiency (\>1.5mg/dL)
* Cardiogenic shock
* Acute myocardial infarction within one week
* Prior coronary artery bypass graft treatment
* Prior percutaneous coronary intervention treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR