CompletedNot Applicable

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

China1,586 participantsStarted 2021-02-11

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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; Exclusion Criteria: * 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 visit…

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT04918030

SponsorXiamen Cardiovascular Hospital, Xiamen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-01