Sponsor Name : Elixir Medical Corporation
The INFINITY-SWEDEHEART trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor: Resolute Onyx)
The INFINITY-SWEDEHEART study will evaluate the safety and effectiveness of the DynamX Bioadaptor compared to the Resolute Onyx in the treatment of patients with ischemic heart disease with de novo native coronary artery lesions in epicardial vessels.
Two thousand four hundred (2400) patients will be recruited over a 12-month period with a 5-year follow-up period.
Primary Endpoint(s): Device Oriented Clinical Endpoint (DOCE) of target lesion failure (TLF; cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR)) at 1 year.
Defined as any myocardial infarction not clearly attributed to a non-target vessel.
Acute Success endpoints:
- Device Success (Lesion Level Analysis)
- Procedural Success (Patient Level Analysis)
Approximately 20 participating sites in Sweden.