Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients

First Affiliated Hospital Xi'an Jiaotong University1 site in 1 country1,000 target enrollmentJuly 1, 2020

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Enrollment: 1000
Locations: 1
Primary Endpoint: Composite ischemic events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective registry to enroll complex high-risk coronary heart disease patients.

The purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.

Registry

clinicaltrials.gov

Start Date

July 1, 2020

End Date

December 2023

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Bifurcation lesions with branch diameter ≥2.5mm;
•Chronic complete occlusion (occlusion duration ≥3 months);
•Left main disease;
•Long lesions (≥38mm);
•Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation);
•Multi-stent implantation (≥3 stents);
•In-stent restenosis;
•Moderate to severe calcification on radiography;
•Intermediate lesion;
•Thrombotic lesions;

Exclusion Criteria

•Informed consent cannot be obtained;
•Life expectancy \< 1 year.

Outcomes

Primary Outcomes

Composite ischemic events

Time Frame: 24 months

Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.