Precision Therapy in Complex High-risk Coronary Artery Disease

NCT ID: NCT04444960

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intracoronary physiology and imaging-guided group

percutaneous coronary intervention

Intervention Type PROCEDURE

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

Angiography-guided group

percutaneous coronary intervention

Intervention Type PROCEDURE

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

Interventions

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percutaneous coronary intervention

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xin Huang, phD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Huang, PhD

Role: CONTACT

008613571961135

Facility Contacts

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Xin Huang, phD

Role: primary

008613571961135

Other Identifiers

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XJTU1AF-CRF-2019-014

Identifier Type: -

Identifier Source: org_study_id

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