An observational study in Chronic Total Occlusion and Coronary Artery Disease, sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Ruijin Hospital · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
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Patients with coronary artery disease and CTO undergone coronary angiography at Ruijin Hospital, Shanghai, China will be consecutively enrolled.
Exclusion Criteria:
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.
Procedure: Coronary angiography
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.
Procedure: Coronary angiography
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.
Time frame: Immediate post-angiography
Composite event of all-cause mortality, non-fatal myocardial infarction, heart failure and repeat revascularization
Time frame: up to 5 years
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
The level of serum markers and biochemical indexes which have been reported to closely related to cardiovascular diseases and collateral formation.
Time frame: up to 5 years
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