An interventional study of ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA) and DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) in Acute Myocardial Infarction, sponsored by A.O. Ospedale Papa Giovanni XXIII. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-23.
Sponsored by A.O. Ospedale Papa Giovanni XXIII · Not applicable, Interventional, and Treatment
The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (\~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.
Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.
955 studies on the registry are indexed under Thrombosis; 171 are open to participants now.
This study's enrollment of 44 is below the median of 83 across 530 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →A.O. Ospedale Papa Giovanni XXIII is the lead sponsor of 32 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Zotarolimus Drug eluting stents in overlap
Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA) · Device: Coronary stent implantation
Bare metal stent
Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca) · Device: Bare Metal Coronary Stent
ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
DRIVER bare metal stent implanted in acute myocardial infarction
Comparison of Drug Eluting versus Bare Metal Stent
Also known as: Zotarolimus Eluting Coronary Stent
Comaprison between Drug Eluting and Bare Metal Coronary Stents
Also known as: Driver Coronary Stent
Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent
Non inferiority
Time frame: 6 months
number of well apposed stent struts without neointima
number of well apposed stent struts without neointima
Time frame: 6 months
number of malapposed stent struts without neointima
number of malapposed stent struts without neointima
Time frame: 6 months
number of sections with > 30% uncovered struts/total struts
number of sections with \> 30% uncovered struts/total struts
Time frame: 6 months
Number of sections with incomplete strut apposition
Number of sections with incomplete strut apposition
Time frame: 6 months
Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)
Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)
Time frame: 6 months
In segment OCT neontimal volume
In segment OCT neontimal volume
Time frame: 6 months
This study is completed, as verified in May 2022. 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.
A.O. Ospedale Papa Giovanni XXIII