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Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast)
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.
Details
| Lead sponsor | Philips Clinical & Medical Affairs Global |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 371 |
| Start date | Tue Oct 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Feb 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Coronary Artery Disease
Interventions
- Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
- Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
Countries
Belgium, United States, Israel, Spain