CTO Registry From Insight of IVUS in Fuwai Hospital

Coronary Heart Disease Clinical Trial

— FWCTO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03461367
• Other study ID #: 20180223
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Chronic Total Occlusion of Coronary Artery
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Intravascular Ultrasound
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Locations

Country	Name	City	State
China	Lei Song	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel revascularization	Any ischemic driven revascularization of the target vessel	5-year follow-up after index PCI
Secondary	All-cause death	Any cause of death	Within the first 1 month after PCI and during the 5-year follow-up
Secondary	Cardiac death	Cardiac death	Within the first 1 month after PCI and during the 5-year follow-up
Secondary	Myocardial infarction	Any myocardial infarction including perioperative MI	Within the first 1 month after PCI and during the 5-year follow-up
Secondary	Stroke	Ischemic or hemorrhagic stroke	Within the first 1 month after PCI and during the 5-year follow-up
Secondary	Major adverse cardiac and cerebrovascular events (MACCE)	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