Dynamic Change of Coronary Artery Curvature — DC3  

Coronary Artery Disease Clinical Trial

Official title: Dynamic Change of Coronary Artery Curvature After Adaptive Remodeling

Status Not yet recruiting

Clinical Trial Summary

The novolimus-eluting DynamX bioadaptor system is composed of 71 µm cobalt-chromium sinusoidal rings connected to each other axially by three S-links Each ring contains three uncaging elements that are positioned at equal distance in low stress regions of struts oriented in a helical configuration along the length of the bioadaptor which remain intact after uncaging. The uncaging elements consist of three separable junctions per ring held together by a 6 µm polymer coating that is resorbed over six months, allowing uncaging of the vessel and adaptive remodeling. Previous study showed the DynamX biodaptor is safe and effective treating in de novo coronary lesion. It also increased of vessel and device area while maintain in the mean lumen area after one year follow-up. However, the unchanging effect of Dynamx bioadaptor on coronary geometry change remained unknown. The present randomized control study is designed to investigate the differences of dynamic coronary artery geometry changes evaluated by coronary computed tomography angiography after DynamX Bioadaptor and permanent metallic DES implantation.

Clinical Trial Description

Coronary artery disease (CAD) is the most common type of heart disease and the leading cause of death worldwide. Percutaneous coronary intervention and coronary artery bypass graft are the guideline suggested treatment. Drug-eluting stents (DES) is the guideline suggested treatment options. Percutaneous coronary intervention with DES provides not just acute luminal gains, but also good long-term patency and clinical outcomes. However, in-stent neoatherosclerosis, very late stent thrombosis, and endothelial dysfunction remained important long-term issues. In addition, metallic stent encages the vessel segment, limits its remodeling and vasomotor function. The original vessel geometry, curvature, tortuosity, and wall shear stress, which are associated with plaque formation are also changed permanently by stent implantation. Although bioresorbable scaffolds attempted to address these issues by providing structural support to the vessel early on, followed by resorption, randomized trials showed that, prior to their resorption, they were less safe and effective than contemporary DES. Since that, the novel DES, DynamX Bioadaptor, is designed to improve these limitations.

The novel DES, DynamX Bioadaptor, is designed to restore normal pulsatility and adaptive remodeling in blood vessels after stent implantation. It is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. Segments of the stent are held together by the polymer coating, which is designed to be fully absorbed in 6 months. After degradation of polymer, the stent struts unlink and uncage the stented segment. Pilot study demonstrated vessel uncaging and restoration of cyclic pulsatility 12 months after DynamX Bioadaptor implantation. Adaptive remodeling 12 months after DynamX Bioadaptor implantation will restore flexibility and natural geometry of the stented vessel segment. Thus, the dynamic beat-to-beat (cardiac cycle) changes of curvature and tortuosity will be more pronounced in the DynamX Bioadaptor group compared with that in the permanent metallic Elixir DESyne DES group. The DynamX Bioadaptor can potentially restore the vessel geometry and improve outcomes. The present randomized control study is designed to investigate the differences of dynamic coronary artery geometry changes after DynamX Bioadaptor and permanent metallic DES implantation, using coronary computed tomography angiography (CCTA) as an evaluation tool. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT04936191
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Hsien-Li Kao, MD
• Phone: +886-2-23123456
• Email: hsienli_kao@yahoo.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Completion date: December 2023