NCT04918030

STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）

STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease （STAGED）

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,586 (actual)
• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in major adverse cardiac event (MACE) between Early staged PCI versus Late staged PCI groups among patients with ST-segment elevated myocardial infarction （STEMI and multi-vessel Disease（MVD) who underwent primary PCI using DES for culprit lesions. Background: In patients with STEMI with MVD who underwent primary PCI, complete revascularization for non-culprit lesions has proved to reduce the risk of cardiovascular death and myocardial infarction. However, the ideal timing point for staged PCI for nonculprit lesions remains uncertain.

Detailed description

A total of 1586 subjects with STEMI who met inclusion criteria and had no any exclusion criterion will be randomized (at a 1:1 ratio) to Early staged PCI group and Late staged PCI group. After successful percutaneous coronary intervention for culprit lesion, staged PCI for all non-culprit vessel with significant lesion defined at least 80% diameter stenosis by visual estimation and accompanied by a QFR measurement of less than or equal to 0.80 will be performed. Patients will be ranmized to the following groups at 1:1 ratio: 1. Patients randomized to the in-hospital staged PCI (Early group) will undergo PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion. 2. Patients randomized to out-hospital staged complete revascularization (Late group) will undergo PCI for all significant non-culprit lesions at 30±15 days after primary PCI.

Conditions

• STEMI
• Multi Vessel Coronary Artery Disease
• Percutaneous Coronary Intervention
• AMI Patients With Multivessel Disease, Staged PCI

Interventions

Type	Name	Description
PROCEDURE	Early staged PCI	After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).
PROCEDURE	Late staged PCI	During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 30±15 days to undergo PCI of the other significant coronary lesions.

Timeline

• Start date: 2021-02-11
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2021-06-08
• Last updated: 2025-12-12

Locations

1 site across 1 country: China