Studies a dissolving heart stent in people with coronary artery disease
Checks the safety and performance of a dissolving stent in adults with heart artery disease.
Plain-language title generated from the registry record
Registry title: DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
Key facts
- Where
- Ho Chi Minh City and Kiến Giang, VietnamSee the 2 sites
Where in Vietnam
- Tam Duc Heart HospitalHo Chi Minh City, VietnamTaking people
- Kiến Giang General HospitalKiến Giang, VietnamTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Elixir Medical Corporation
- Trial code
- NCT06074549
- Record updated
- 28 August 2025
- Original description
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.Read full original descriptionShow less
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
Inclusion: Over 18 years of age; Patient understands the trial requirements and treatment procedures and provides informed consent; Patient indicated for PCI with stent implantation and receive at least one DynamX Bioadaptor implant in accordance with the product's Instructions for Use (IFU).
Exclusion: Prior venous or arterial bypass grafts; Patient is currently participating in another clinical trial with an investigational device or an investigational drug that has the potential to impact study results (e.g., anti-thrombotic or anti-platelet medications) that has not yet completed its primary endpoint; Target Lesion(s) in the left main artery; In-stent restenosis; Patient is, in the opinion of the Investigator, unable to comply with the requirements of the study protocol or is unsuitable for the registry for any reason.