Trials / Completed
CompletedNCT04085614
Dynamic Coronary Roadmap for Contrast Reduction
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 371 (actual)
- Sponsor
- Philips Clinical & Medical Affairs Global · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired coronary angiograms during the same procedure. Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries. This is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial to assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Detailed description
Primary objective: • To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap. Secondary objective: • To assess the total number of contrast enhanced cine angiographic X-ray runs (angiograms) related to Percutaneous Coronary Intervention (PCI) in the Dynamic Coronary Roadmap and control group
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap | Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap |
| DEVICE | Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap | Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2023-02-09
- Completion
- 2023-02-09
- First posted
- 2019-09-11
- Last updated
- 2024-01-08
- Results posted
- 2024-01-08
Locations
6 sites across 4 countries: United States, Belgium, Israel, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04085614. Inclusion in this directory is not an endorsement.