Chronic Total Occlusion of Coronary Artery, Coronary Heart Disease, Intravascular Ultrasound, Percutaneous Coronary Intervention
Conditions
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.
Interventions
None listed
Sponsors
China National Center for Cardiovascular Diseases
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target vessel revascularization | 5-year follow-up after index PCI | Any ischemic driven revascularization of the target vessel |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | Within the first 1 month after PCI and during the 5-year follow-up | Any cause of death |
| Cardiac death | Within the first 1 month after PCI and during the 5-year follow-up | Cardiac death |
| Myocardial infarction | Within the first 1 month after PCI and during the 5-year follow-up | Any myocardial infarction including perioperative MI |
| Stroke | Within the first 1 month after PCI and during the 5-year follow-up | Ischemic or hemorrhagic stroke |
| 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 |
Countries
China
Outcome results
None listed