Trials / Recruiting
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)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,000 (estimated)
- Sponsor
- Elixir Medical Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 coronary artery lesions in a real-world patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DynamX 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 |
Timeline
- Start date
- 2024-03-10
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2023-10-10
- Last updated
- 2025-08-28
Locations
17 sites across 9 countries: Austria, Curacao, Indonesia, Italy, Jordan, Saudi Arabia, Turkey (Türkiye), United Arab Emirates, Vietnam
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06074549. Inclusion in this directory is not an endorsement.