Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963620
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-07-27
First Post:
2023-07-19
Brief Title:
Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery
Sponsor:
Heart Center Leipzig - University Hospital
Organization:
Heart Center Leipzig - University Hospital
Study Overview
Official Title:
Long-term Follow-up of a Randomized Comparison of Percutaneous Coronary Intervention Versus Coronary Artery Bypass Surgery in Unprotected Left Main Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
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:
This is a long-term follow-up of a completed clinical trial which compared percutaneous coronary intervention PCI using sirolimus-eluting stents and coronary artery bypass grafting CABG in patients with unprotected left main coronary artery disease
The purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population
The purpose of the study is to obtain retrospective long-term data on clinical outcome of the study population
Detailed Description:
The randomized multicenter open-label trial Percutaneous Coronary Intervention PCI With Drug-Eluting Stents DES Versus Coronary Artery Bypass Graft CABG for Patients With Significant Left Main Stenosis was conducted at 4 tertiary care centers in Germany 201 patients with unprotected left main stem stenosis 50 with or without additional multivessel coronary artery disease were enrolled in a 11 ratio from July 2003 through February 2009 Results were published httpspubmedncbinlmnihgov21272743
Long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation Wherever possible data will be completed and verified by health care records Retrospective data of the underlying randomized study will be included in data analysis
Long-term follow-up will be performed by a structured telephone interview using a standardized questionnaire by an interviewer blinded to treatment allocation Wherever possible data will be completed and verified by health care records Retrospective data of the underlying randomized study will be included in data analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None