EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Total Occlusion of Coronary Artery

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Hu Tao, M.D.; Phone Number: 13363999556; Email: dr_ht556@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing CTO PCI at each of the participating centers

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Lumen Loss	Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up.	1 year after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Lumen Loss	Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up.	3 year after PCI
Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE)	including any of the following adverse events before hospital discharge: death from any cause, Q-wave myocardial infarction, recurrent symptoms Heart and Vessels requiring urgent repeat target vessel revascularization with PCI or CABG, tamponade requiring either pericardiocentesis or surgery, and stroke.	Within the first week after PCI, at the 1-year follow-up and at the 3-year follow-up
Complications	Any periprocedural complication was defined as the composite of death, myocardial infarction, stent thrombosis, stroke, vessel perforation, vascular access complications, need for emergency surgical intervention or PCI, and hemoglobin reduction by >3 g/dL.	Within the first week after PCI

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital
• Collaborators: Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Chronic Total Occlusion; Intravascular Ultrasound; True Lumen; False Lumen
• Other Study ID Numbers: LAOHUOJI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No