Clinical trial NCT04965207: EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation
Official title: EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation (LAOHUOJI): a CTO All-comer Register Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Total Occlusion of Coronary Artery
Keywords: Chronic Total Occlusion
Intravascular Ultrasound
Percutaneous Coronary Intervention
True Lumen
False Lumen
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Xijing Hospital
First posted: 2021-07-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing CTO PCI at each of the participating centers

Brief summary: IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO.

Detailed description: At present, novel technologies of CTO interventional therapy become mature. These technologies usually artificially cause dissection of coronary artery. The events such as collateral vessel loss, vascular injury and tear, perforation, pericardial tamponade caused by false lumen may theoretically affect the perioperative and long-term prognosis of patients. In this study, intravascular ultrasound (IVUS) was used to evaluate the characteristics of true lumen and false lumen in CTO segment, so as to determine its impact on the prognosis of patients.

Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old;
* be diagnosed with CTO;
* CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5mm;
* comply with all the evaluations and follow-up protocols.

Exclusion Criteria:

* suffered from acute myocardial infarction within the previous 3 months;
* rheumatic valvular disease;
* severe arrhythmia;
* lesions unsuitable for PCI;
* severely abnormal hematopoietic systems, such as platelet counts \<100\*10\^9/L or \> 700\*10\^9/L and white blood cell counts \< 3\*10\^9/L;
* with active bleeding or bleeding tendencies(active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency);
* severe coexisting conditions, including severe renal function dysfunction \[Glomerular filtration rate less than 60ml/min • 1.73 m2), severe hepatic dysfunction \[glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference\], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months;
* a life expectancy less than 12 months;
* pregnancy or planning to become pregnant;
* history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents;
* cannot tolerate dual antiplatelet treatment;
* unable to communicate due to cognitive impairment, auditory, or visual impairment;
* participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.

Primary outcomes:
measure: Late Lumen Loss
timeFrame: 1 year after PCI
Secondary outcomes:
measure: Late Lumen Loss
timeFrame: 3 year after PCI
measure: Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE)
timeFrame: Within the first week after PCI, at the 1-year follow-up and at the 3-year follow-up
measure: Complications
timeFrame: Within the first week after PCI
Other outcomes:
Locations:
Study officials:
References: