Clinical trial NCT03461367: CTO Registry From Insight of IVUS in Fuwai Hospital
Official title: Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Registry From Insight of Intravascular Ultrasound in Fuwai Hospital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Heart Disease
Chronic Total Occlusion of Coronary Artery
Percutaneous Coronary Intervention
Intravascular Ultrasound
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2018-03-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CTO Patients who underwent PCI with contemporary CTO techniques by certified operators in Fuwai Hospital.

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Target vessel revascularization
timeFrame: 5-year follow-up after index PCI
Secondary outcomes:
measure: All-cause death
timeFrame: Within the first 1 month after PCI and during the 5-year follow-up
measure: Cardiac death
timeFrame: Within the first 1 month after PCI and during the 5-year follow-up
measure: Myocardial infarction
timeFrame: Within the first 1 month after PCI and during the 5-year follow-up
measure: Stroke
timeFrame: Within the first 1 month after PCI and during the 5-year follow-up
measure: Major adverse cardiac and cerebrovascular events (MACCE)
timeFrame: Within the first 1 month after PCI and during the 5-year follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Song
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Catheter Lab
name: Bo Xu
role: STUDY_DIRECTOR
References: