Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00768846
Status:
UNKNOWN
Last Update Posted:
2008-10-15
First Post:
2008-10-06
Brief Title:
Zotarolimus and Everolimus-Eluting Stents ProsPectively Compared in Real World
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Randomized Comparison of Zotarolimus- and Everolimus-Eluting Stents for Coronary Treatment
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZEPPELIN
Brief Summary:
The zotarolimus-eluting Endeavor Resolute stent is not inferior to the everolimus- eluting Xience V stent platform regarding a composite of cardiac death myocardial infarction or target lesion revascularisation in a real-world population
Detailed Description:
The use of stents has become common practice in the percutaneous treatment of coronary artery disease Restenosis affected 20-40 of de novo coronary lesions treated with bare metal stents Drug-eluting stents DES have emerged as the most effective strategy for the prevention of restenosis The first available DES were the Sirolimus-eluting Cypher and the Paclitaxel-eluting Taxus stent Although their mid-term efficacy has been well-established there is an ongoing debate on the potential of an increased incidence of late stent thrombosis as well as of delayed onset of restenosis or catch-up phenomenon with DES Recent evidence demonstrates that there might be differences between various DES in terms of safety and efficacy The differences might be related to the drug polymer or stent design Everolimus SDZ-RAD and zotarolimus ABT-578 are new antiproliferative agents that share some common structural and biological properties with sirolimus limus-group Both drugs bind to the intracellular sirolimus receptor FK 506-binding protein 12 FKBP 12 The drug-FKBP12 complex inhibits cell cycle progression via inactivation of the mammalian target of Rapamycin mTOR thereby regulating vascular smooth muscle cell migration and proliferation Preclinical studies showed improved endothelialization and limited chronic inflammation of the everolimus-eluting stent compared with previous drug-eluting stents Moreover first randomized clinical trials of everolimus-eluting stents have shown promising results regarding safety feasibility and efficacy in the suppression of neointimal proliferation Safety and efficacy of the zotarolimus-eluting Endeavor stent have been investigated in the Endeavor clinical program In the Endeavor III and IV trials the Endeavour stent proved inferior to the Cypher and Taxus stents regarding angiographic endpoints However rates of target vessel failure were similar in both groups The Endeavor RESOLUTE stent platform uses a new polymer with potential improvements of drug release compared to the Endeavor stent The RESOLUTE clinical trial is the first-in man observational uncontrolled non-randomized study evaluating the Endeavor Resolute drug-eluting stent with the new polymer The trial enrolled a total of 130 patients with native coronary artery lesions There are no data available comparing the zotarolimus-eluting Endeavor Resolute stent with the everolimus-eluting Xience V stent Thus the aim of this prospective randomized study is to compare the efficacy and safety of these two new generation drug-eluting stent platforms in a real world population
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