Chronic Total OcclusionNCT06137521
Risk Factors and Outcomes in Coronary Chronic Total Occlusion
An observational study of Chronic Total Occlusion and Coronary Artery Disease, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion, Coronary Artery Disease
- What is being tested?
- Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients with coronary artery disease and CTO undergone coronary angiography at Ruijin Hospital, Shanghai, China will be consecutively enrolled.
Who may be able to join
- Age ≥18 years; Patients with angina or silent ischemia and documented ischemia; Patients with CTO ≥ 3months
Who cannot join
- eGFR<15mL/(min·1.73m2); Chronic heart failure with NYHA grade ≥3; Had a history of coronary artery bypass grafting; Had received a percutaneous coronary intervention within the prior 3 months; Malignant tumor or immune system disorders; Pulmonary heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Jian Li, 0086 021 64370045, ruijincrc@126.com
About this study
Official title: Risk Factors and Outcomes in Patients With Stable Coronary Artery Disease and Coronary Chronic Total Occlusion
This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment.
Read the detailed description
Coronary artery disease (CAD) is still one of the major contributors to global mortality. CTO is a special lesion type of CAD, defined as complete occlusion of at least one major epicardial coronary artery more than 3 months. Compared to non-CTO patients, those with CTO have worse prognosis. The prognosis of CTO patients is related to many factors including the baseline characteristics, modality of treatment and the degree of coronary collateral formation. Figuring out the factors which can indicate the outcomes of CTO is essential to clinical decision making. In this single center, observational study, we collect patient's clinical characteristics and blood samples to investigate potential factors associated with the development of coronary collateral formation and outcomes in patents with stable coronary artery disease.
- Conditions
- Chronic Total Occlusion, Coronary Artery Disease
- Being tested
- Coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with good coronary collaterals | Coronary collateral circulation development was graded according to the Rentrop score, grade 2 (partial filling of the epicardial segment by collateral vessels); grade 3 (complete filling of the epicardial artery by collateral vessels) were defined as good coronary collateral circulation. Receives: Procedure: Coronary angiography | |
| Patients with poor coronary collaterals | Coronary collateral circulation development was graded according to the Rentrop score, grade 0 (no filling of any collateral vessels) and grade 1 (filling of side branches of the artery to be perfused by collateral vessels without visualization of the epicardial segment) were defined as poor coronary collateral circulation. Receives: Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of collateral estimated visually by Rentrop score during coronary angiography
The degree of coronary collateralization supplying the distal area of the total coronary occlusion was visually graded using the Rentrop scoring system as follows: 0=no visible collaterals; 1=poorly opacified collaterals with faint visualization of the distal vessel; 2=partial filling of the collateral vessels; and 3=complete filling of the collateral vessels. Patients were then classified as poor coronary collaterals (Rentrop scores of 0 and 1) or good coronary collaterals (Rentrop scores of 2 and 3), according to the Rentrop score.
Measured: Immediate post-angiography
Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization
Measured: up to 5 years
Secondary outcomes (7)
Event of all-cause mortality
Measured: up to 5 years
Event of death from cardiac causes
Measured: up to 5 years
Event of heart failure
Measured: up to 5 years
The change of left ventricular ejection fraction
Measured: 1 year
Events of repeat revascularization
Measured: up to 5 years
Event rate of procedural success
Measured: Immediate post-PCI
Event of procedural outcomes
Measured: 1 month post-angiography or PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2010
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fenghua Ding, PhD, MD, Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137521
- Sponsor's protocol ID
- RFOCTO
- Status last verified
- Aug 2026
- First submitted
- 13 Nov 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Outcomes in Patients With Stable Coronary Artery Disease and Coronary Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT06137521
- Acronym / sponsor ID
- RFOCTO
- Conditions
- Chronic Total Occlusion, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Nov 2023 (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.
This study aims to assess the risk factors and evaluate the long-term outcomes of patients with coronary chronic total occlusion (CTO) treated with percutaneous coronary intervention or medical treatment.
Detailed description
Coronary artery disease (CAD) is still one of the major contributors to global mortality. CTO is a special lesion type of CAD, defined as complete occlusion of at least one major epicardial coronary artery more than 3 months. Compared to non-CTO patients, those with CTO have worse prognosis. The prognosis of CTO patients is related to many factors including the baseline characteristics, modality of treatment and the degree of coronary collateral formation. Figuring out the factors which can indicate the outcomes of CTO is essential to clinical decision making. In this single center, observational study, we collect patient's clinical characteristics and blood samples to investigate potential factors associated with the development of coronary collateral formation and outcomes in patents with stable coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with good coronary collaterals | – | Procedure: Coronary angiographyCoronary collateral circulation development was graded according to the Rentrop score, grade 2 (partial filling of the epicardial segment by collateral vessels); grade 3 (complete filling of the epicardial artery by collateral vessels) were defined as good coronary collateral circulation. |
| Patients with poor coronary collaterals | – | Procedure: Coronary angiographyCoronary collateral circulation development was graded according to the Rentrop score, grade 0 (no filling of any collateral vessels) and grade 1 (filling of side branches of the artery to be perfused by collateral vessels without visualization of the epicardial segment) were defined as poor coronary collateral circulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease and CTO undergone coronary angiography at Ruijin Hospital, Shanghai, China will be consecutively enrolled.
Key inclusion criteria (1 listed)
- Age ≥18 years; Patients with angina or silent ischemia and documented ischemia; Patients with CTO ≥ 3months
Key exclusion criteria (1 listed)
- eGFR<15mL/(min·1.73m2); Chronic heart failure with NYHA grade ≥3; Had a history of coronary artery bypass grafting; Had received a percutaneous coronary intervention within the prior 3 months; Malignant tumor or immune system disorders; Pulmonary heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiography | Procedure or surgery | Patients with good coronary collaterals, Patients with poor coronary collaterals |
Primary outcome
The degree of collateral estimated visually by Rentrop score during coronary angiography
Time frame: Immediate post-angiography
The degree of coronary collateralization supplying the distal area of the total coronary occlusion was visually graded using the Rentrop scoring system as follows: 0=no visible collaterals; 1=poorly opacified collaterals with faint visualization of the distal vessel; 2=partial filling of the collateral vessels; and 3=complete filling of the collateral vessels. Patients were then classified as poor coronary collaterals (Rentrop scores of 0 and 1) or good coronary collaterals (Rentrop scores of 2 and 3), according to the Rentrop score.
Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization
Time frame: up to 5 years
7 secondary outcomes
Event of all-cause mortality
Time frame: up to 5 years
Event of death from cardiac causes
Time frame: up to 5 years
Event of heart failure
Time frame: up to 5 years
The change of left ventricular ejection fraction
Time frame: 1 year
Events of repeat revascularization
Time frame: up to 5 years
Event rate of procedural success
Time frame: Immediate post-PCI
Event of procedural outcomes
Time frame: 1 month post-angiography or PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
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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.
Fenghua Ding, PhD, MD study chair
Ruijin Hospital
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 Chronic Total Occlusion and Coronary Artery Disease, run by Ruijin Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fenghua Ding, PhD, MD (0086 021 64370045, ruijindfh@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of collateral estimated visually by Rentrop score during coronary angiography (time frame: Immediate post-angiography). The study lists 2 primary outcomes in all. 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 18 Aug 2026.