Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422968
Status:
COMPLETED
Last Update Posted:
2014-05-01
First Post:
2007-01-16
Brief Title:
Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease
Sponsor:
Seung-Jung Park
Organization:
CardioVascular Research Foundation Korea
Study Overview
Official Title:
PREmier of Randomized COMparison of Bypass Surgery Versus AngioplasTy Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2014-04
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:
PRECOMBAT
Brief Summary:
The primary objective of the PRE-COMBAT trial is
To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent Cordis Johnson Johnson Warren New Jersey compared with bypass surgery for the treatment of an unprotected LMCA stenosis The alternative hypothesis is that the experimental strategy coronary stenting with the sirolimus-eluting stents is not inferior to the standard strategy bypass surgery
To establish the safety and effectiveness of coronary stenting with the sirolimus-eluting balloon expandable stent Cordis Johnson Johnson Warren New Jersey compared with bypass surgery for the treatment of an unprotected LMCA stenosis The alternative hypothesis is that the experimental strategy coronary stenting with the sirolimus-eluting stents is not inferior to the standard strategy bypass surgery
Detailed Description:
Despite bypass surgery has been considered as the standard strategy for the treatment of unprotected left main coronary artery LMCA lesions several studies have demonstrated that percutaneous coronary intervention PCI of the unprotected LMCA is feasible and appears to be an alternative strategy in selected patients However the safety and efficacy of PCI in patients with unprotected LMCA stenosis are still a matter of debate
Previous studies have demonstrated the safety and feasibility of unprotected LMCA intervention using bare metal stents BMS There was a favorable initial outcome after LMCA intervention using BMS in low-risk patients However in-stent restenosis after BMS implantation has emerged as the interference to widely perform PCI for unprotected LMCA lesions and the most important reason for selection of bypass surgery as the first choice for treating LMCA stenosis In-stent restenosis in these patients not only influences long-term survival but also make repeat intervention more complex Despite endeavors to decrease in-stent restenosis after LMCA intervention using BMS such as aggressive debulking atherectomy the restenosis rate still remains at 20-30 The sirolimus-eluting stent SES Cypher Cordis Johnson Johnson Corp Miami Florida markedly decreases in-stent restenosis in elective patients with relatively simple coronary lesions In real-world practice using SES patients undergoing SES implantation were treated with a less restrictive interventional approach However the results are very promising similar to the randomized controlled trials These findings warrant new studies to compare the efficacy of SES for more complex lesion subsets including LMCA disease with coronary artery bypass graft CABG
Previous studies have demonstrated the safety and feasibility of unprotected LMCA intervention using bare metal stents BMS There was a favorable initial outcome after LMCA intervention using BMS in low-risk patients However in-stent restenosis after BMS implantation has emerged as the interference to widely perform PCI for unprotected LMCA lesions and the most important reason for selection of bypass surgery as the first choice for treating LMCA stenosis In-stent restenosis in these patients not only influences long-term survival but also make repeat intervention more complex Despite endeavors to decrease in-stent restenosis after LMCA intervention using BMS such as aggressive debulking atherectomy the restenosis rate still remains at 20-30 The sirolimus-eluting stent SES Cypher Cordis Johnson Johnson Corp Miami Florida markedly decreases in-stent restenosis in elective patients with relatively simple coronary lesions In real-world practice using SES patients undergoing SES implantation were treated with a less restrictive interventional approach However the results are very promising similar to the randomized controlled trials These findings warrant new studies to compare the efficacy of SES for more complex lesion subsets including LMCA disease with coronary artery bypass graft CABG
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