Status:
RECRUITING
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
Lead Sponsor:
Elixir Medical Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief 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.
Detailed Description
This registry will obtain additional safety, effectiveness, and performance data on the DynamX Coronary Bioadaptor System in the treatment of patients with ischemic heart disease due to de novo native...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT06074549
Start Date
March 10 2024
End Date
December 1 2028
Last Update
August 28 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital St. Pölten
Pölten, Austria
2
Curaçao Medical Center
Willemstad, Curacao
3
Heartology Cardiovascular Hospital
Jakarta, Indonesia
4
Jakarta Heart Center
Jakarta, Indonesia