Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375063
Status:
COMPLETED
Last Update Posted:
2006-09-12
First Post:
2006-09-11
Brief Title:
Study of Unprotected Left Main Stenting Versus Bypass Surgery LE MANS Study
Sponsor:
Ministry of Science and Higher Education Poland
Organization:
Ministry of Science and Higher Education Poland
Study Overview
Official Title:
Prospective Randomized Study of Unprotected Left Main Stenting Versus Bypass Surgery
Status:
COMPLETED
Status Verified Date:
2006-09
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:
Unprotected left main coronary artery ULMCA stenting offering restoration of a native flow to left coronary artery is the subject of intense investigations as a potential alternative to bypass surgery The purpose of the study is to compare the short and long term results of unprotected left main stenting with coronary artery bypass surgery
Detailed Description:
The natural history and the results of pharmacological treatment in patients with severe narrowing of left main coronary artery show very poor prognosis 5 year survival less than 50
There is general agreement that surgical treatment improves 5 year survival in patients with left main coronary artery obstruction 3 however long term survival rate 15 year follow-up is low in both groups 37 and 27 respectively in surgical and medical group Median survival was longer in surgical group in general population 133 vs 66 years but there was no significant difference in patients with normal LV ejection fraction 147 vs 15 years
With the advent of coronary stenting encouraging results were reported by several authors There was high success rate 98-100 for elective procedures and in these series the mortality for protected and non-protected left main ranged from 0 to 34 and 6 month event free survival rate was 70-80 Restenosis rate in stented LM varied from 10-22 for proximal LM to 40 for distal LM Final minimal luminal area 7mm2 post procedure assessed by IVUS predicted low restenosis rate of 7 while the area below 7mm2 was connected with restenosis of 50 Our and other experience showed that left main in-stent restenosis can be treated successfully with another percutaneous intervention including endarterectomy and balloon angioplasty as well as by surgical revascularization
Six and 12-month survival rate depended on the LV function Patients with LVEF40 had in-hospital event free survival of 98 and 9-month event free survival of 86 whereas patients with LVEF 40 had in-hospital and 9 month event-free survival of 67 and 22 respectively Additionally in patients presented with acute myocardial infarction or bail-out procedures early and late results of LM stenting were not as good as for elective cases
Our previously presented promising results of left main stenting is mainly related to proper technique of LM stenting short inflations within LM careful guiding catheter manipulation stent selection as well as very cautiously designed follow-up every month visit for first six month routine coronary angiography within 3-6 months after procedure This initial experience gives us the backgrounds for a larger prospective randomized trial comparing elective surgical revascularisation and percutaneous intervention in patients with LM coronary artery disease It is our impression that design and the delivery system of the new generation stent is uniquely suited to safely treat this difficult subset of patients At the present time we would limit the study to the discrete lesions in proximal ostial and mid left main with reference luminal diameter 3 mm Based on published results of stenting under IVUS examination for such a lesion we estimate the restenosis rate to be well below 10 As we expect the survival and complication rate within one year in both group will be similar Therefore our main concern is weather both treatment strategies will offer the same prevention of LV function as well as improvement of functional capacity and coronary reserve in both groups in a period of 2-3 years
There is general agreement that surgical treatment improves 5 year survival in patients with left main coronary artery obstruction 3 however long term survival rate 15 year follow-up is low in both groups 37 and 27 respectively in surgical and medical group Median survival was longer in surgical group in general population 133 vs 66 years but there was no significant difference in patients with normal LV ejection fraction 147 vs 15 years
With the advent of coronary stenting encouraging results were reported by several authors There was high success rate 98-100 for elective procedures and in these series the mortality for protected and non-protected left main ranged from 0 to 34 and 6 month event free survival rate was 70-80 Restenosis rate in stented LM varied from 10-22 for proximal LM to 40 for distal LM Final minimal luminal area 7mm2 post procedure assessed by IVUS predicted low restenosis rate of 7 while the area below 7mm2 was connected with restenosis of 50 Our and other experience showed that left main in-stent restenosis can be treated successfully with another percutaneous intervention including endarterectomy and balloon angioplasty as well as by surgical revascularization
Six and 12-month survival rate depended on the LV function Patients with LVEF40 had in-hospital event free survival of 98 and 9-month event free survival of 86 whereas patients with LVEF 40 had in-hospital and 9 month event-free survival of 67 and 22 respectively Additionally in patients presented with acute myocardial infarction or bail-out procedures early and late results of LM stenting were not as good as for elective cases
Our previously presented promising results of left main stenting is mainly related to proper technique of LM stenting short inflations within LM careful guiding catheter manipulation stent selection as well as very cautiously designed follow-up every month visit for first six month routine coronary angiography within 3-6 months after procedure This initial experience gives us the backgrounds for a larger prospective randomized trial comparing elective surgical revascularisation and percutaneous intervention in patients with LM coronary artery disease It is our impression that design and the delivery system of the new generation stent is uniquely suited to safely treat this difficult subset of patients At the present time we would limit the study to the discrete lesions in proximal ostial and mid left main with reference luminal diameter 3 mm Based on published results of stenting under IVUS examination for such a lesion we estimate the restenosis rate to be well below 10 As we expect the survival and complication rate within one year in both group will be similar Therefore our main concern is weather both treatment strategies will offer the same prevention of LV function as well as improvement of functional capacity and coronary reserve in both groups in a period of 2-3 years
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