DynamX Novolimus-eluting Coronary Bioadaptor System
DeviceAll patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use
Other names: DynamX Bioadaptor
NCT Number: NCT06074549
The goal of this registry is to confirm the safety, and performance of the DynamX Coronary Bioadaptor System in patients with coronary artery disease.
Interested in participating?
Request Info18 year and older
All sexes
Observational
University Hospital St. Pölten, Pölten, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients will receive at least one DynamX Bioadaptor implant in a commercial setting in accordance with the product's Instructions for Use
Other names: DynamX Bioadaptor
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 30 days
Composite of TLF: cardiovascular death, target vessel myocardial infarction (TV-MI), or clinically indicated target lesion revascularization (CI-TLR), per ARC-2
Time frame: 30 days and 12 months
Composite of all-cause death, any stroke, any myocardial infarction (MI) (includes non-target vessel territory) and any revascularization.
Time frame: 30 days and 12 months
Composite of cardiovascular death, TV-MI, or target vessel revascularization (TVR).
Time frame: 30 days and 12 months
Target lesion, target vessel, non-target lesion, non-target vessel; clinically driven and non-clinically driven.
Time frame: 30 days and 12 months
Target and non-target vessel
Time frame: 30 days and 12 months
Cardiovascular, Non-Cardiovascular, Unknown
Time frame: 30 days and 12 months
Time frame: 30 days and 12 months
Time frame: 30 days and 12 months
Time frame: 30 days and 12 months
Contact information is provided by the study sponsor or research team.
Elixir Medical Corporation
Industry
DynamX Bioadaptor Global Post-Market Registry: Clinical Trial of the Elixir Medical DynamX Coronary Bioadaptor System (Bio-RESTORE)
Acronym: Bio-RESTORE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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