Precision Therapy in Complex High-risk Coronary Artery Disease (PTCA)

Xi'an Jiaotong University

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: percutaneous coronary intervention

Study type: Observational

Funder types: Other

Identifiers

NCT04444960

XJTU1AF-CRF-2019-014

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 2 patient groups

Intracoronary physiology and imaging-guided group

Treatment:

Procedure: percutaneous coronary intervention

Angiography-guided group

Treatment:

Procedure: percutaneous coronary intervention