CTO Registry From Insight of IVUS in Fuwai Hospital

NCT03461367 | Unknown

• 1 other identifier: 20180223
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease; Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Intravascular Ultrasound

Outcome Measures

Primary Outcomes (1)

• Target vessel revascularization

  Any ischemic driven revascularization of the target vessel

  5-year follow-up after index PCI

Secondary Outcomes (5)

• All-cause death

  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

  Within the first 1 month after PCI and during the 5-year follow-up

• Stroke

  Within the first 1 month after PCI and during the 5-year follow-up

• Major adverse cardiac and cerebrovascular events (MACCE)

  Within the first 1 month after PCI and during the 5-year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Lei Song

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bo Xu

  Fuwai Hospital, Catheter Lab

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 12, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

CN (1)