Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422565
Status:
TERMINATED
Last Update Posted:
2022-12-07
First Post:
2007-01-16
Brief Title:
Zotarolimus-Versus Sirolimus-Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
Sponsor:
Seung-Jung Park
Organization:
CardioVascular Research Foundation Korea
Study Overview
Official Title:
Comparison of the Efficacy and Safety of Zotarolimus-Eluting Stent Versus Sirolimus-Eluting Stent Versus PacliTaxel-Eluting Stent for Acute Myocardial Infarction Patients
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The recruitment rate was much slower than expected
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEST-AMI
Brief Summary:
The trial has the following primary objective
To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent Medtronic Minneapolis MN vs sirolimus-eluting balloon expandable stent Cordis Johnson Johnson Warren New Jersey vs paclitaxel-eluting stent Taxus Liberte Boston Scientific
To compare the safety and effectiveness of primary acute MI intervention with ABT 578-eluting balloon expandable stent Medtronic Minneapolis MN vs sirolimus-eluting balloon expandable stent Cordis Johnson Johnson Warren New Jersey vs paclitaxel-eluting stent Taxus Liberte Boston Scientific
Detailed Description:
Previous studies have documented that a slow-release polymeric sirolimus-eluting stent Cypher Cordis and paclitaxel-eluting stent Taxus Boston Scientific reduce neointimal formation and result in decrease of angiographic restenosis and target lesion revascularization at 1-3 years in the multicenter randomized clinical trials RAVEL SIRIUS and TAXUS I-VI From these studies the two leading drug-eluting stents DESs of the Cypher and Taxus have been widely and rapidly accepted as a standard treatment of coronary lesions
Recently randomized studies were conducted to reveal different outcomes of the different two DESs These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes A recent meta-analysis supported results of the former randomized studies Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent
With a recent approval of new DES ABT-578-eluting stent Endeavor Medtronic Minneapolis MN other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline PC-coated ABT-578-eluting stent for the prevention of restenosis Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14 and a late lumen loss of 03 mm with a low frequency of target lesion revascularization 1 The clinical outcomes from the ENDEAVOR II 1197 patients randomized to ABT-578 or bare metal stent showed superior efficacy of the PC-coated ABT-578-eluting stent than bare-metal stent
In patients with acute myocardial infraction MI routine stent implantation has been shown to have a better procedural success rate and clinical outcome than balloon angioplasty 11 However restenosis and vessel reocclusion remain major challenges limiting the long-term success of percutaneous treatment
In a clinical study of 400 patients with stent implantation in acute MI angiographic restenosis occurred in 31 considerably more than expected for patients with stable coronary disease There is very little information available as to the efficacy and long-term safety of DES in acute MI The results from the several registry and randomized trials Cypher-AMI Typhoon PASSION demonstrated the short-term or long-term safety and efficacy of DES compared to BMS
The incomplete evidence to date is that implantation of SES in patients with Acute MI is safe and effective more than BMS and results of implantation of PES are at variance with the results of the BMS However up to date there are randomized trials to compare the efficacy and safety among commonly used DES zotarolimus- vs sirolimus- vs paclitaxel-eluting stents for the treatment of acute MI patients The results of large randomized trials and larger registries will allow us to make evidence-based decisions about which stent to use in patients with acute MI Therefore we designed a randomized controlled partially blinded trial comparing the safety and efficacy of the zotarolimus vs sirolimus vs paclitaxel stents in acute MI patients undergoing percutaneous coronary intervention
Recently randomized studies were conducted to reveal different outcomes of the different two DESs These studies showed that the sirolimus-eluting stent was better than the paclitaxel-eluting stent in terms of lower angiographic restenosis rate or the two DESs were similar in angiographic outcomes A recent meta-analysis supported results of the former randomized studies Patients receiving sirolimus-eluting stent had a significantly lower risk of restenosis and target vessel revascularization compared with those receiving paclitaxel-eluting stent
With a recent approval of new DES ABT-578-eluting stent Endeavor Medtronic Minneapolis MN other comparison studies have been conducted to compare Endeavor ABT-578-eluting stent with the sirolimus-eluting stent and paclitaxel-eluting stent The ENDEAVOR clinical trials are currently in progress to evaluate a phosphoryl choline PC-coated ABT-578-eluting stent for the prevention of restenosis Angiographic analysis at 4 months in the 100-patient focal de novo lesion ENDEAVOR I feasibility study demonstrated a mean in-stent percent diameter stenosis of approximately 14 and a late lumen loss of 03 mm with a low frequency of target lesion revascularization 1 The clinical outcomes from the ENDEAVOR II 1197 patients randomized to ABT-578 or bare metal stent showed superior efficacy of the PC-coated ABT-578-eluting stent than bare-metal stent
In patients with acute myocardial infraction MI routine stent implantation has been shown to have a better procedural success rate and clinical outcome than balloon angioplasty 11 However restenosis and vessel reocclusion remain major challenges limiting the long-term success of percutaneous treatment
In a clinical study of 400 patients with stent implantation in acute MI angiographic restenosis occurred in 31 considerably more than expected for patients with stable coronary disease There is very little information available as to the efficacy and long-term safety of DES in acute MI The results from the several registry and randomized trials Cypher-AMI Typhoon PASSION demonstrated the short-term or long-term safety and efficacy of DES compared to BMS
The incomplete evidence to date is that implantation of SES in patients with Acute MI is safe and effective more than BMS and results of implantation of PES are at variance with the results of the BMS However up to date there are randomized trials to compare the efficacy and safety among commonly used DES zotarolimus- vs sirolimus- vs paclitaxel-eluting stents for the treatment of acute MI patients The results of large randomized trials and larger registries will allow us to make evidence-based decisions about which stent to use in patients with acute MI Therefore we designed a randomized controlled partially blinded trial comparing the safety and efficacy of the zotarolimus vs sirolimus vs paclitaxel stents in acute MI patients undergoing percutaneous coronary intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None