Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133237
Status:
COMPLETED
Last Update Posted:
2010-03-15
First Post:
2005-08-22
Brief Title:
Drug-eluting-stents for Unprotected Left Main Stem Disease ISAR-LEFT-MAIN
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Prospective Randomized Trial of the Sirolimus-Eluting Stent and Paclitaxel-Eluting Stent for the Treatment of Unprotected Left Main Coronary Artery DiseaseISAR-LEFT-MAIN
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy of sirolimus- and paclitaxel-eluting stents for treatment of unprotected left main coronary artery disease
Detailed Description:
With the advent of coronary stents and improvements in periprocedural antithrombotic regimen the spectrum of indications of percutaneous coronary interventions has continuously expanded for patients with coronary heart disease gaining ground in what have been traditionally considered as domains of coronary bypass surgery Several groups reported the outcomes of patients with unprotected left main coronary artery LMCA disease treated with stenting Most of them found that LMCA stenting was feasible and safe and in low-risk patients it was associated with minimal periprocedural complications and low long-term morbidity and mortality Despite these encouraging reports a widespread use of this technique has been hampered by the still high incidence of restenosis It is commonly accepted that coronary bypass graft surgery and stenting for unprotected LMCA disease are associated with similar rates of mortality and that the higher incidence of restenosis and greater need for revascularization procedures after LMCA stenting remain the major contributors for the observed difference in clinical efficacy between both therapies The recent introduction of stents eluting anti-restenotic drugs with sirolimus and paclitaxel the most studied compounds has opened new perspectives for the prevention of restenosis Several randomized trials have reported excellent results in the reduction of restenosis and need for reinterventions with drug-eluting stents DES Although none of these trials studied the benefit of DES for lesions located in the LMCA their results suggested that use of these new devices may be particularly helpful for the reduction of restenosis in the group of patients with left main trunk disease This is supported by the findings of several series of patients with unprotected LMCA disease who have been successfully treated with DES Importantly for patients who are unable to undergo CABG due to cardiac surgeons refusal poor surgical candidates or their own unwillingness stenting with DES remains the only revascularization alternative Recent guidelines of PCI recommend stenting preferentially with DES for unprotected LMCA in the absence of other revascularization options
Comparison
Sirolimus-eluting stents compared with paclitaxel-eluting stent for treatment of lesions allocated at left main trunk
Comparison
Sirolimus-eluting stents compared with paclitaxel-eluting stent for treatment of lesions allocated at left main trunk
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