DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System

Study Overview
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Brief Summary
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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
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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.

Official Title
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DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Novolimus Eluting Coronary Bioadaptor System (Bio-RESTORE)

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DynamX Novolimus-eluting Coronary Bioadaptor System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Label<br>DynamX Novolimus-eluting Coronary Bioadaptor System | Device: DynamX Novolimus-eluting Coronary Bioadaptor System<br>* All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use<br>* Other names: DynamX Bioadaptor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Oriented Clinical Endpoint | 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 | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Device Success | Achievement of a final residual stenosis <30% by QCA or visual estimation, using the study device and without a device deficiency | In-Hospital, assessed up to 7 days after procedure | 
| Clinical Procedural Success | 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 | In-Hospital, assessed up to 7 days after procedure | 
| Device Oriented Clinical Endpoint | Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2 | 30 days | 
| Patient Oriented Clinical Endpoint | Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization. | 30 days and 12 months | 
| Rate of target vessel failure (TVF) | Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR). | 30 days and 12 months | 
| Rate of all revascularization | Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven. | 30 days and 12 months | 
| Rate of all MI | Target and non-target vessel | 30 days and 12 months | 
| Rate of all-cause death | Cardiovascular, Non-Cardiovascular, Unknown | 30 days and 12 months | 
| 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 |