CTO Registry From Insight of IVUS in Fuwai Hospital

Active, not recruiting

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

• Registration Number: NCT03461367
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

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 Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target vessel revascularization	5-year follow-up after index PCI	Any ischemic driven revascularization of the target vessel

Secondary Outcome Measures

Name	Time	Method
All-cause death	Within the first 1 month after PCI and during the 5-year follow-up	Any cause of death
Myocardial infarction	Within the first 1 month after PCI and during the 5-year follow-up	Any myocardial infarction including perioperative MI
Major adverse cardiac and cerebrovascular events (MACCE)	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
Cardiac death	Within the first 1 month after PCI and during the 5-year follow-up	Cardiac death
Stroke	Within the first 1 month after PCI and during the 5-year follow-up	Ischemic or hemorrhagic stroke

Trial Locations

Locations (1)

Lei Song; 🇨🇳 Beijing, Beijing, China