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

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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

Trial contacts and locations

1

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Central trial contact

Xin Huang, PhD

Data sourced from clinicaltrials.gov

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