To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Ischemia-driven Target Lesion Revascularization (TLR)
Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.
Time frame: 6 months
QCA & IVUS derived parameters
Late Loss, Restenosis Rate, %DS, MLD \& Neointimal Volume
Time frame: 12 months
Major Adverse Coronary Events
Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK \> 2xULN + MB\>ULN) (MI), and target vessel revascularization (TVR).
Time frame: 60 months
Procedural and Technical Success
percentage of patients with angiographic success successful delivery and deployment of the device
Time frame: Acute
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