DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System
- Conditions
- Coronary Artery Disease
- Interventions
- Device: DynamX Novolimus-eluting Coronary Bioadaptor System
- Registration Number
- NCT06074549
- Lead Sponsor
- Elixir Medical Corporation
- Brief Summary
The goal of this registry is to confirm the safety, and performance of the DynamX Novolimus Eluting Coronary Bioadaptor System in patients with coronary artery disease.
- Detailed Description
This registry will obtain additional safety, effectiveness, and performance data on the DynamX Novolimus-Eluting 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- 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).
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Open Label DynamX Novolimus-eluting Coronary Bioadaptor System DynamX Novolimus-eluting Coronary Bioadaptor System
- Primary Outcome Measures
Name Time Method Device Oriented Clinical Endpoint 12 Months Composite of Target Lesion Failure (TLF): cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2
- Secondary Outcome Measures
Name Time Method Rate of all MI 30 days and 12 months Target and non-target vessel
Clinical Procedural Success In-Hospital, assessed up to 7 days after procedure Achievement of a final residual stenosis \<30% by QCA or visual estimation, using the study device, with or without any adjunctive devices, and without TLF
Device Oriented Clinical Endpoint 30 days Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2
Rate of target vessel failure (TVF) 30 days and 12 months Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).
Rate of all revascularization 30 days and 12 months Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven.
Rate of all-cause death 30 days and 12 months Cardiovascular, Non-Cardiovascular, Unknown
Clinical Device Success In-Hospital, assessed up to 7 days after procedure Achievement of a final residual stenosis \<30% by QCA or visual estimation, using the study device and without a device deficiency
Patient Oriented Clinical Endpoint 30 days and 12 months Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization.
Composite of cardiovascular death, any myocardial infarction, and any revascularization 30 days and 12 months Rate of stroke 30 days and 12 months Rate of probable or definite stent thrombosis 30 days and 12 months Duration of DAPT 30 days and 12 months
Trial Locations
- Locations (1)
King Fahad Armed Forces Hospital
🇸🇦Jeddah, Saudi Arabia