Coronary Heart DiseaseFWCTONCT03461367
CTO Registry From Insight of IVUS in Fuwai Hospital
An observational study of Coronary Heart Disease and Chronic Total Occlusion of Coronary Artery, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CTO Patients who underwent PCI with contemporary CTO techniques by certified operators in Fuwai Hospital.
Who may be able to join
- 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.
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention, Intravascular Ultrasound
- Medical subject headings
- Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel revascularization
Any ischemic driven revascularization of the target vessel
Measured: 5-year follow-up after index PCI
Secondary outcomes (5)
All-cause death
Any cause of death
Measured: Within the first 1 month after PCI and during the 5-year follow-up
Cardiac death
Cardiac death
Measured: Within the first 1 month after PCI and during the 5-year follow-up
Myocardial infarction
Any myocardial infarction including perioperative MI
Measured: Within the first 1 month after PCI and during the 5-year follow-up
Stroke
Ischemic or hemorrhagic stroke
Measured: Within the first 1 month after PCI and during the 5-year follow-up
Major adverse cardiac and cerebrovascular events (MACCE)
Including all-cause death, myocardial infarction, stroke or any target vessel revascularization
Measured: Within the first 1 month after PCI and during the 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lei Song, MD, China National Center for Cardiovascular Diseases
- Investigators
- Bo Xu, Study director, Fuwai Hospital, Catheter Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461367
- Sponsor's protocol ID
- 20180223
- Acronym
- FWCTO
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Chronic Total Occlusion Percutaneous Coronary Intervention Registry From Insight of Intravascular Ultrasound in Fuwai Hospital
- ClinicalTrials.gov ID
- NCT03461367
- Acronym / sponsor ID
- FWCTO / 20180223
- Conditions
- Coronary Heart Disease, Chronic Total Occlusion of Coronary Artery, Percutaneous Coronary Intervention, Intravascular Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CTO Patients who underwent PCI with contemporary CTO techniques by certified operators in Fuwai Hospital.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target vessel revascularization
Time frame: 5-year follow-up after index PCI
Any ischemic driven revascularization of the target vessel
5 secondary outcomes
All-cause death
Time frame: 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
Myocardial infarction
Time frame: 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
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: Within the first 1 month after PCI and during the 5-year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Xu study director
Fuwai Hospital, Catheter Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Chronic Total Occlusion of Coronary Artery, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel revascularization (time frame: 5-year follow-up after index PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.