Precision Therapy in Complex High-risk Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— PTCA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04444960
• Other study ID #: XJTU1AF-CRF-2019-014
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: August 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xin Huang, PhD
• Phone: 008613571961135
• Email: hearthx[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• percutaneous coronary intervention
Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite ischemic events	Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.	24 months