Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures

Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures - Xres5 image processing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48824

Enrollment

305

Registered

2018-07-12

Start date

2018-10-31

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease ischemic heart disease

Interventions

Live cine image processing with Xres5 (Phase 1a) during cardiac catheterization and live Xres5 fluoroscopy processing (Phase 1d, 2/3). + (at least) one cine run performed with a lower contrast mediu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Subject will be undergoing an elective coronary catheterization. • Subject is 18 years of age or older.

Exclusion criteria

Exclusion criteria: • Contrast allergies • Severe kidney disease (e-GFR

Design outcomes

Primary

Measure	Time frame
The outcome of the study will be a set of fine-tuned enhanced performance Xres5 X-ray protocols (cine and fluoroscopy) for different imaging conditions.	—

Secondary

Measure	Time frame
1. The lowest achievable concentration of contrast medium and radiation dose which do not cause loss of relevant clinical information in the image. 2. A semi-quantitative comparison of IQ and diagnostic performance of reduced radiation and contrast runs processed with Xres5 compared to the standard of care runs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)