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

NCT04918030 | Completed DMC

• 1 other identifier: 2020YLK14
• Study Type: interventional
• Target: 1,586
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

AMI, multivessel disease, PCI, staged complete revascularization

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions).

  The difference in MACE will be calculated from randomisation to 12 months.

  12 months

Secondary Outcomes (7)

• All-cause death

  12 months

• Myocardial Infarction (MI)

  12 months

• Revascularization

  12 months

• Cardiovascular death

  12 months

• Heart failure-induced rehospitalization

  12 months

Other Outcomes (1)

• Stent thrombosis

  12 months

Study Arms (2)

Early staged group

ACTIVE COMPARATOR

Patients randomized to Early group will undergo staged PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion.

Procedure: Early staged PCI

Late staged PCI

EXPERIMENTAL

Patients randomized to Late Group will undergo staged PCI for all significant non-culprit lesion at 30±15 days after primary PCI for culprit coronary lesions.

Procedure: Late staged PCI

Interventions

Early staged PCI PROCEDURE

After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).

Also known as: Percutaneous coronary intervention

Early staged group

Late staged PCI PROCEDURE

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.

Also known as: Percutaneous coronary intervention

Late staged PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures;
• Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
• Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
• De novo coronary lesion,
• TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure.
• At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5;

You may not qualify if:

• Age \<18 yr and \>80 yr;
• Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
• Killip classification \>3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
• Previous documented allergic reaction to drug and device of this study;
• Planned major surgery within 6 weeks in which impact DAPT;
• Participation in another clinical study, interfering with this protocol Uncertain;
• Life expectancy \< 1 year;
• Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.

Sponsors & Collaborators

• Xiamen Cardiovascular Hospital, Xiamen University: lead
• Nanjing First Hospital, Nanjing Medical University: collaborator

Study Sites (1)

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361000, China

Location

Related Publications (1)

• Chen X, Li S, Wang B, Chen G, Yao Y, He Y, Wu X, Yang Y, Kang H, Ding L, Cheng Y, Shen Q, Guo H, Wang J, Wen S, Zhu L, Xing Y, Tong Q, Li P, Liu Y, Peng X, Chen SL, Wang Y. Staged interventional strategies for acute ST-segment elevation myocardial infarction patient with multivessel disease: Rationale and design of a multicenter, randomized STAGED trial. Am Heart J. 2026 May;295:107352. doi: 10.1016/j.ahj.2026.107352. Epub 2026 Jan 13.

  PMID: 41539383 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Yan Wang, Dr

  Clinical Trial Center of Xiamen Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 8, 2021
• Study Start: February 11, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: One year lafter since publication
• Access Criteria: All can access via reaching to PIs

Locations

CN (1)