- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03461367
CTO Registry From Insight of IVUS in Fuwai Hospital (FWCTO)
February 7, 2023 updated by: Lei Song, MD, China National Center for Cardiovascular Diseases
Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Registry From Insight of Intravascular Ultrasound in Fuwai Hospital
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.
Study Overview
Status
Active, not recruiting
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 Type
Observational
Enrollment (Anticipated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Lei Song
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
CTO Patients who underwent PCI with contemporary CTO techniques by certified operators in Fuwai Hospital.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target vessel revascularization
Time Frame: 5-year follow-up after index PCI
|
Any ischemic driven revascularization of the target vessel
|
5-year follow-up after index PCI
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause death
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
|
Any cause of death
|
Within the first 1 month after PCI and during the 5-year follow-up
|
Cardiac death
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
|
Cardiac death
|
Within the first 1 month after PCI and during the 5-year follow-up
|
Myocardial infarction
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
|
Any myocardial infarction including perioperative MI
|
Within the first 1 month after PCI and during the 5-year follow-up
|
Stroke
Time Frame: Within the first 1 month after PCI and during the 5-year follow-up
|
Ischemic or hemorrhagic stroke
|
Within the first 1 month after PCI and during the 5-year follow-up
|
Major adverse cardiac and cerebrovascular events (MACCE)
Time Frame: 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
|
Within the first 1 month after PCI and during the 5-year follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Bo Xu, Fuwai Hospital, Catheter Lab
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ANTICIPATED)
December 31, 2024
Study Completion (ANTICIPATED)
December 31, 2025
Study Registration Dates
First Submitted
March 3, 2018
First Submitted That Met QC Criteria
March 8, 2018
First Posted (ACTUAL)
March 12, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 7, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20180223
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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