RecruitingNCT06074549
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)
Sponsor
Elixir Medical Corporation
Enrollment
5,000 participants
Start Date
Mar 10, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria5
- Target Lesion(s) in the left main artery
- Prior venous or arterial bypass grafts
- In-stent restenosis
- 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
- 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
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Interventions
DEVICEDynamX Novolimus-eluting Coronary Bioadaptor System
All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06074549
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