A Multicenter Registration Study of Complex High-risk PCI Patients

NCT07557238 | Not Yet Recruiting DMC

• 1 other identifier: 2026-3151
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Coronary Artery Disease

Keywords

complex PCI, prediction model, patient registry

Outcome Measures

Primary Outcomes (1)

• One year post PCI all-cause mortality

  One year post PCI all-cause mortality

  One year after PCI

Secondary Outcomes (7)

• One year postoperative major adverse cardiovascular events (MACE)

  One year after PCI

• Cardiac death 1 year after PCI

  One year after PCI

• Postoperative 1-year myocardial infarction

  One year after PCI

• TVR 1 year after PCI

  One year after PCI

• Re hospitalization due to heart failure 1 year after PCI

  One year after PCI

Study Arms (1)

patients with complex PCI

Left ventricular ejection fraction (LVEF) ≤ 35%, or LVEF ≤ 40% with severe mitral regurgitation, complex PCI meets one of the following criteria: a) Unprotected left main artery disease; 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with complex PCI

You may qualify if:

• 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

You may not qualify if:

• 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 cardiac index\<2.2L/min/m2; ③ There is a phenomenon of organ hypoperfusion, including a decrease in limb skin temperature, a decrease in urine output\<30ml/h, consciousness disorders or an increase in lactate\>2mmol/L);

Sponsors & Collaborators

• Guofeng Gao: lead
• Shenzhen Core Medical Technology CO.,LTD.: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04