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

National Center for Cardiovascular Diseases

Status: Active, not recruiting

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

Study type: Observational

Funder types: Other

Identifiers

NCT03461367

20180223

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%