NCT06074549 DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System
| NCT ID | NCT06074549 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elixir Medical Corporation |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-03-10 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2024-03-10 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Over 18 years of age 2. Patient understands the trial requirements and treatment procedures and provides informed consent 3. 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 Criteria: 1. Target Lesion(s) in the left main artery 2. Prior venous or arterial bypass grafts 3. In-stent restenosis 4. 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 5. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06074549 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06074549 currently recruiting?
Yes, NCT06074549 is actively recruiting participants. Contact the research team at ltanner@ElixirMedical.com for enrollment information.
Where is the NCT06074549 trial being conducted?
This trial is being conducted at Pölten, Austria, Willemstad, Curacao, Jakarta, Indonesia, Jakarta, Indonesia and 11 additional locations.
Who is sponsoring the NCT06074549 clinical trial?
NCT06074549 is sponsored by Elixir Medical Corporation. The trial plans to enroll 5,000 participants.