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Status unknownNCT04444960PTCAUpdated Aug 21, 2020

Precision Therapy in Complex High-risk Coronary Artery Disease

An observational study in Coronary Artery Disease, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2020-08-21.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Aug 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 336 across 1,946 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Coronary heart disease patients with complicated clinical conditions and/or complex coronary lesions.

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

Exclusion Criteria:

  • Informed consent cannot be obtained;
  • Life expectancy \< 1 year.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • Intracoronary physiology and imaging-guided group

    Procedure: percutaneous coronary intervention

  • Angiography-guided group

    Procedure: percutaneous coronary intervention

Interventions

  • Procedurepercutaneous coronary intervention

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

06

What researchers measure

Primary outcomes

  1. Composite ischemic events

    Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04444960
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Responsible party
Sponsor
First posted
Jun 24, 2020
Start date
Jul 1, 2020
Primary completion
Jun 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Aug 21, 2020

Study contacts

Xin Huang, PhD
Contact
hearthx@126.com
008613571961135
Xin Huang, phD
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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