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

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04965207

Collaborator

Xijing Hospital (Other)

1,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Late Lumen Loss [3 year after PCI]
Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up.
Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE) [Within the first week after PCI, at the 1-year follow-up and at the 3-year follow-up]
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.
Complications [Within the first week after PCI]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

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 <10010^9/L or > 70010^{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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Shanghai 10th People's Hospital
Xijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ya-Wei Xu, Chief physician, Shanghai 10th People's Hospital

ClinicalTrials.gov Identifier:

NCT04965207

Other Study ID Numbers:

LAOHUOJI

First Posted:

Jul 16, 2021

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ya-Wei Xu, Chief physician, Shanghai 10th People's Hospital

Chronic Total Occlusion

Intravascular Ultrasound

Percutaneous Coronary Intervention

True Lumen

False Lumen

Study Results

No Results Posted as of Sep 28, 2021