I25.1
Conditions
Interventions
Group 1: DynamX Novolimus-Eluting Coronary Bioadaptor System
Sponsors
Angiopro
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. 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
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 study for any reason 6. Exclusion criteria which, according to the IFU, contraindicate treatment with the study device 7. Pregnancy or suspected pregnancy and breastfeeding 8. Life expectation less than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is Device Oriented Clinical Endpoint composite at 6 and 12 months (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute Success endpoints after procedure - Clinical Device Success (Lesion Level Analysis) - Clinical Procedural Success (Patient Level Analysis) Clinical endpoints, tabulated at In-Hospital/Discharge, 6 months, and and 12 months: - Device Oriented Clinical Endpoint hierarchical composite (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI) (not clearly attributable to a non-target vessel), clinically indicated target lesion revascularization (CI-TLR)) - Patient Oriented Clinical Endpoint hierarchical composite (all- cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization) - All revascularization (target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven) - All MI (target and non-target vessel) - All-cause death (Cardiovascular, Non-Cardiovascular, Unknown)‡ - Stroke - Duration of DAPT | — |
Countries
Germany
Contacts
Public ContactStephan Achenbach
Universitätsklinikum Erlangen
Outcome results
None listed