Ignite Creation Date:
2024-05-06 @ 2:03 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01960933
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-28
First Post:
2013-10-09
Brief Title:
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease Treatment of Culprit Lesion Only or Complete Revascularization
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease Treatment of Culprit Lesion Only or Complete Revascularization DANAMI-3-PRIMULTI A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
PRIMULTI
Brief Summary:
In patients with ST-elevation myocardial infarction STEMI the primary treatment is acute angioplasty of the acute occlusion culprit lesion In STEMI patients with multi vessel disease MVD no evidence based treatment of the non-culprit lesions exists We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient
Detailed Description:
STEMI patients with MVD 30 of total STEMI population are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention PCI of other lesions or full revascularisation guided by fractional flow reserve FFR
Eligible coronary arteries must be 20 mm in diameter and at the discretion of the operator suitable for PCI Only arteries with angiographically stenoses 50 can be randomized All randomized lesions with diameter stenosis 50 and 90 are evaluated by FFR and a FFR value 080 is considered significant and treated Stenoses 90 are treated without prior FFR
Full revascularization is a priori obtained by means of PCI If however PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen
Eligible coronary arteries must be 20 mm in diameter and at the discretion of the operator suitable for PCI Only arteries with angiographically stenoses 50 can be randomized All randomized lesions with diameter stenosis 50 and 90 are evaluated by FFR and a FFR value 080 is considered significant and treated Stenoses 90 are treated without prior FFR
Full revascularization is a priori obtained by means of PCI If however PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen
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