Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01399736
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2011-07-20
Brief Title:
Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD
Sponsor:
Maasstad Hospital
Organization:
Maasstad Hospital
Study Overview
Official Title:
Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
Status:
COMPLETED
Status Verified Date:
2020-05
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:
CompareAcute
Brief Summary:
The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease who are admitted into hospital with a ST-elevation Myocardial Infarction The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only
Patients will be enrolled after successful revascularisation of the culprit vessel Patients that have at least one lesion with a diameter of stenosis of more than 50 on visual estimation feasible operators judgement for treatment with PCI in a non-infarct related artery will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina
Approximately 885 patients will be entered in the study
Study hypothesis FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation guided by prove of ischemia or clinical judgment as recommended from the guidelines
Patients will be enrolled after successful revascularisation of the culprit vessel Patients that have at least one lesion with a diameter of stenosis of more than 50 on visual estimation feasible operators judgement for treatment with PCI in a non-infarct related artery will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina
Approximately 885 patients will be entered in the study
Study hypothesis FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation guided by prove of ischemia or clinical judgment as recommended from the guidelines
Detailed Description:
Background of the study At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated While the previous guidelines stead that these lesions should be treated in a second time ie not during the primary intervention the actual guidelines do not touch this argument The reason is that the studies where the previous guidelines were based are old Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers non randomised trials from USA still recommend the staged treatment For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment as well as the new medical therapy and PCI techniques
Objective of the study FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation guided by prove of ischemia or clinical judgment as recommended from the guidelines
Study design Prospective 1 2 randomisation FFR guided revascularisation during primary PCI 1 versus following actual guidelines 2
Study population All STEMI patients between 18-85 years who will be treated with primary PCI in 12 h more than 12 hr if persisting pain allowed after the onset of symptoms and have at least one stenosis of 50 in a non-IRA judged feasible for treatment with PCI
Intervention if applicable FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation guided by prove of ischemia or clinical judgment as recommended from the guidelines
Primary study parametersoutcome of the study Composite endpoint of all cause mortality non-fatal Myocardial Infarction any Revascularisation and Stroke MACCE at 12 months
Objective of the study FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation guided by prove of ischemia or clinical judgment as recommended from the guidelines
Study design Prospective 1 2 randomisation FFR guided revascularisation during primary PCI 1 versus following actual guidelines 2
Study population All STEMI patients between 18-85 years who will be treated with primary PCI in 12 h more than 12 hr if persisting pain allowed after the onset of symptoms and have at least one stenosis of 50 in a non-IRA judged feasible for treatment with PCI
Intervention if applicable FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation guided by prove of ischemia or clinical judgment as recommended from the guidelines
Primary study parametersoutcome of the study Composite endpoint of all cause mortality non-fatal Myocardial Infarction any Revascularisation and Stroke MACCE at 12 months
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