Clinical Evaluation of Radiation Reduction for Optimized Safety

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAngiowave Imaging

About this trial

The primary objective of this study is to determine whether a reduced radiation protocol (RRP) in which angiograms are acquired at ultralow radiation doses and then processed using spatiotemporal enhancement software can produce similar quality angiographic images as compared with standard techniques.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Referred for clinically indicated coronary angiography

≥18 years of age

Not pregnant

English speaking

Disqualifiers

Hemodynamically or electrically unstable.

Indication for coronary angiography is emergent, including ST-segment elevation myocardial infarction

History of coronary artery bypass grafting

An eGFR <60

Trial population

Patients suspected to have coronary artery disease (CAD) who are undergoing diagnostic coronary angiography with or without possible percutaneous coronary intervention (PCI).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Segment-level percent diameter stenosis (%DS)

Segment-level quantitative coronary angiography (QCA) determination of percent diameter stenosis (%DS)

Time frame
Periprocedural

Secondary outcomes

1

Stenosis severity

Agreement in reader-adjudication of segment-level identification of mild/intermediate/severe stenosis

Time frame
Periprocedural
2

Diagnostic quality

Percent of coronary segments qualitatively determined to be of adequate diagnostic image quality

Time frame
Periprocedural
3

Radiation dose - SOC

Radiation dose (air kerma and dose-area product) for SOC-angiograms

Time frame
Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: