Not Yet RecruitingNot Applicable

A Multicenter Registration Study of Complex High-risk PCI Patients

1,000 participantsStarted 2026-05-01

Plain-language summary

This study is a prospective, multicenter, observational registry study (based on real-world data). Participants who meet all inclusion and exclusion criteria will be included in this study for the collection of clinical and imaging data, as well as subsequent follow-up. The main objective is to evaluate the incidence and predictive factors of all-cause mortality in CHIP patients one year after PCI surgery. The secondary objectives include evaluating the incidence and predictive factors of major cardiovascular adverse events (MACE) in CHIP patients one year after PCI surgery; Compare the efficacy differences of different revascularization strategies (complete/incomplete revascularization); Analyze the impact of imaging/functional tools (IVUS/OCT/FFT/QFR) on the prognosis of CHIP-PCI; Analyze the impact of MCS on the prognosis of CHIP-PCI; Establish a CHIP patient risk prediction model

Who can participate

Age range18 Years – 90 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: * 18 years old ≤ patient ≤ 90 years old; * The patient is willing to comply with the research protocol requirements and data collection procedures, understand the research objectives, and sign an informed consent form; ③ The cardiac team has determined that the patient has indications for coronary artery revascularization, but the risk of CABG is high, or the patient refuses to undergo CABG. After evaluation, the cardiac team believes that PCI can benefit the patient; ④ Left ventricular ejection fraction (LVEF) ≤ 35%, or LVEF ≤ 40% with severe mitral regurgitation ⑤ Complex PCI meets one of the following conditions: a) Unprotected left main trunk lesion b) The last unobstructed coronary PCI c) Three vessel lesions (coronary angiography shows simultaneous stenosis of the anterior descending, circumflex, and right coronary arteries with a degree of stenosis greater than 70%) d) Calcified lesions require coronary plaque rotational atherectomy e) CTO lesions require bilateral contrast imaging or reverse technology Exclusion Criteria: * Acute ST segment elevation myocardial infarction within one week; * Combined cardiogenic shock (cardiogenic shock is defined as simultaneously meeting the following three conditions: ① arterial systolic pressure\<90mmHg for ≥ 30 minutes, or requiring support from vasopressors/inotropic drugs/mechanical circulation to maintain arterial systolic pressure ≥ 90mmHg; ② There is evidence of decreased cardiac output, such as a…

What they're measuring

One year post PCI all-cause mortality

Timeframe: One year after PCI

Trial details

NCT IDNCT07557238

SponsorGuofeng Gao

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2029-12-31