Coronary Artery Disease
Conditions
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.
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.
Interventions
DEVICEDynamX 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
Sponsors
Elixir Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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 |
| Rate of all-cause death | 30 days and 12 months | Cardiovascular, Non-Cardiovascular, Unknown |
| 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 | — |
| Rate of all MI | 30 days and 12 months | Target and non-target vessel |
Countries
Austria, Curacao, Indonesia, Italy, Jordan, Saudi Arabia, Turkey (Türkiye), United Arab Emirates, Vietnam
Contacts
Primary ContactLisa Tanner
Backup ContactElizabeth Lau, PhD
Outcome results
None listed