DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
Recruiting now
Conditions studied: Coronary Artery Disease
In brief
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
Key facts
- Study ID
- NCT06074549
- Run by
- Elixir Medical Corporation
- People needed
- 5000
- Starts
- 2024-03-10
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- University Hospital St. Pölten — Pölten, Austria (enrolling)
- Curaçao Medical Center — Willemstad, Curacao (enrolling)
- Heartology Cardiovascular Hospital — Jakarta, Indonesia (enrolling)
- Jakarta Heart Center — Jakarta, Indonesia (enrolling)
- Medistra Hospital — Jakarta, Indonesia (enrolling)
- Siloam Hospitals — Jakarta, Indonesia (enrolling)
- Centro Cardiologico Monzino — Milan, Italy (enrolling)
- Azienda Ospedaliera Universitaria "Federico II" — Naples, Italy (enrolling)
- Policlinico Tor Vergata — Rome, Italy (enrolling)
- Jordon Hospital — Amman, Jordan (enrolling)
- The Specialty Hospital — Amman, Jordan (enrolling)
- King Fahad Armed Forces Hospital — Jeddah, Saudi Arabia (enrolling)
- Istanbul Medipol Mega University Hospital — Istanbul, Turkey (Türkiye) (enrolling)
- Memorial Bahçelievler Hospital — Istanbul, Turkey (Türkiye) (enrolling)
- Al Qassimi Hospital — Sharjah city, United Arab Emirates (enrolling)
- Tam Duc Heart Hospital — Ho Chi Minh City, Vietnam (enrolling)
- Kiến Giang General Hospital — Kiến Giang, Vietnam (enrolling)
Full record on ClinicalTrials.gov
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