An interventional study of ReZolve Stent in Myocardial Ischemia, Coronary Artery Stenosis and Coronary Disease, sponsored by REVA Medical, Inc.. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by REVA Medical, Inc. · Not applicable, Interventional, and Treatment
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 49 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →REVA Medical, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
Device: ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
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
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
REVA Medical, Inc.