Precision Therapy in Complex High-risk Coronary Artery Disease
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: percutaneous coronary intervention
- Registration Number
- NCT04444960
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
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;
- Creatinine clearance rate < 60ml/min) or on dialysis ;
- Left ventricular ejection fraction <40% ；
- History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract.
Exclusion Criteria
- Informed consent cannot be obtained;
- Life expectancy < 1 year.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Angiography-guided group percutaneous coronary intervention - Intracoronary physiology and imaging-guided group percutaneous coronary intervention -
- Primary Outcome Measures
Name Time Method Composite ischemic events 24 months Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China