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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

NCT04965207•Shanghai 10th People's Hospital

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+3 more criteria

Key Dates

Start Date

October 1, 2021

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2025

Last Updated

September 28, 2021

Enrollment

1,000

ESTIMATED participants

Conditions

Chronic Total Occlusion of Coronary Artery

Contacts

Hu Tao, M.D.

CONTACT

13363999556 dr_ht556@163.com

Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

NCT05813704

Chronic Total Occlusion of Coronary Artery

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RECRUITINGNA

To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.

NCT04944615

Chronic Total Occlusion of Coronary Artery

View study

COMPLETEDNA

Predictors and Long-term Incidence of In-stent Restenosis After Chronic Total Occlusion Percutaneous Coronary Intervention

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.

Predictors and Long-term Incidence of In-stent Restenosis After Chronic Total Occlusion Percutaneous Coronary Intervention

Evaluation of Long Coronary Artery Stents With Third-generation Dual-source Computed Tomography Angiography

Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization

The BLIMP Balloon in Coronary Interventions