CLINICAL EVIDENCE
CLINICAL
EVIDENCE
BIOADAPTOR RCT
Study Design:
- 445 patients enrolled
- 1:1 randomization versus Resolute Onyx DES
- Primary endpoint: TLF at 12 months (powered for non-inferiority)
- Secondary endpoints: Imaging by QCA/IVUS/OCT at 12 months
- Clinical follow-up to 5 years
*Caution: The DynamX Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use.
INFINITY-SWEDEHEART Clinical Trial
Study Design:
- Interventional Clinical Trial
- 2400 participants enrolled in Sweden
- Ages 18 – 85 years
- 1:1 randomization of eligible patients with DynamX : Resolute Onyx
- Intervention Model: Parallel Assignment
Primary Endpoint(s):
- Primary Device Oriented Clinical Endpoint is target lesion failure (TLF); a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).
Powered Secondary Endpoints:
- Landmark analysis of TLF from 6 months to End of Follow-up
- Landmark analysis of TVF from 6 months to End of Follow-up
*Caution: The DynamX Sirolimus Eluting Coronary Bioadaptor System is an investigational device. Limited by Federal (or United States) law to investigational use.
PMN 2145 Rev A