NCT06074549Recruiting
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)
Source: ClinicalTrials.gov · Last updated 28 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 12 Sept 2023
- Start date
- 10 Mar 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- Elixir Medical Corporation
- Diseases
- Coronary artery disease
- NCT number
- NCT06074549
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 10 Mar 2024 to the primary completion date, Dec 2028
- 17 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior venous or arterial bypass grafts
Lab values
- 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
Other
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Al Qassimi Hospital Coordinator of this site? Confirm its status | Sharjah city | United Arab Emirates | Recruiting |
| University hospital St. Pölten Coordinator of this site? Confirm its status | Pölten | Austria | Recruiting |
| Medistra Hospital Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Siloam Hospitals Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Jakarta Heart Center Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Heartology Cardiovascular Hospital Coordinator of this site? Confirm its status | Jakarta | Indonesia | Recruiting |
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Federico II Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Jordon Hospital Coordinator of this site? Confirm its status | Amman | Jordan | Recruiting |
| The Specialty Hospital Coordinator of this site? Confirm its status | Amman | Jordan | Recruiting |
| King Fahad Armed Forces Hospital Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Recruiting |
| Tam Duc Heart Hospital Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Recruiting |
| Kiến Giang General Hospital Coordinator of this site? Confirm its status | Kiến Giang | Vietnam | Recruiting |
| Memorial Bahcelievler Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Istanbul Medipol Mega University Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| Curaçao Medical Center Coordinator of this site? Confirm its status | Willemstad | Curacao | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.