CTO Registry From Insight of IVUS in Fuwai Hospital (FWCTO)

February 7, 2023 updated by: Lei Song, MD, China National Center for Cardiovascular Diseases

Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Registry From Insight of Intravascular Ultrasound in Fuwai Hospital

To evaluate the long-term outcome of chronic total occlusion (CTO) patients underwent contemporary percutaneous coronary intervention (PCI) techniques, we design this single-center, large-sample, prospective registry with five-year clinical follow-up, based on the intravascular ultrasound (IVUS) finding.

Study Overview

Detailed Description

The study plan to include the patients with a CTO lesion in one of the three main epicardial coronary artery (diameter more than 2.5 mm) as the only target lesion. The CTO lesion is defined as 0 grade of thrombolysis in myocardial infarction (TIMI) flow with evidence of occlusion duration more than 3 months. All the PCI procedure will be performed by a group of certified operators in Fuwai Hospital, Beijing, China. All patients evaluate IVUS with automatic pullback (Opticross, Boston Scientific, US) performed after wire crossing. All the included patients are planned for five-year follow-up.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100037
        • Lei Song

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CTO Patients who underwent PCI with contemporary CTO techniques by certified operators in Fuwai Hospital.

Description

Inclusion Criteria:

  • Male or female patient >18 years old
  • Thrombolysis in myocardial infarction trial (TIMI) 0 grade.
  • Evidence of occlusion period more than 3 months.
  • Patients eligible for PCI.
  • Patients eligible for coronary artery bypass graft (CABG).
  • Target vessel is one of the three main epicardial coronary arteries.

Exclusion Criteria:

  • Acute myocardial infarction with ongoing ST-elevation
  • Target vessel is left main or graft vessel.
  • Target vessel diameter < 2.5 mm.
  • Other situations ineligible for PCI judged in clinical practice.
  • Left ventricular ejection fraction <30%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel revascularization
Time Frame: 5-year follow-up after index PCI
Any ischemic driven revascularization of the target vessel
5-year follow-up after index PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
Any cause of death
Within the first 1 month after PCI and during the 5-year follow-up
Cardiac death
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
Cardiac death
Within the first 1 month after PCI and during the 5-year follow-up
Myocardial infarction
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
Any myocardial infarction including perioperative MI
Within the first 1 month after PCI and during the 5-year follow-up
Stroke
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
Ischemic or hemorrhagic stroke
Within the first 1 month after PCI and during the 5-year follow-up
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
Including all-cause death, myocardial infarction, stroke or any target vessel revascularization
Within the first 1 month after PCI and during the 5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Bo Xu, Fuwai Hospital, Catheter Lab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2024

Study Completion (ANTICIPATED)

December 31, 2025

Study Registration Dates

First Submitted

March 3, 2018

First Submitted That Met QC Criteria

March 8, 2018

First Posted (ACTUAL)

March 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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