IVUS VS CAG Guided PCI for Patients With LMB Lesion

NCT04072003 | Unknown

• 1 other identifier: B2018246
• Study Type: observational
• Target: 616
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the 3 - year clinical follow - up results of patients with left main bifurcation lesions treated by intravascular ultrasound(IVUS) - guided and coronary angiography(CAG) - guided percutaneous coronary intervention(PCI), and to confirm the clinical benefits of optimizing interventional therapy of left main bifurcation lesions by intravascular ultrasound(IVUS).

Conditions

Coronary Artery Disease; Left Main Coronary Artery Disease

Keywords

Left main, bifurcation, IVUS,PCI

Outcome Measures

Primary Outcomes (1)

• Target vessel failure rate(the rate of outcomes including cardiac death, target vessel myocardial infarction(MI), and clinically driven main branch or side branch target vessel revascularization(TVR) in each group)

  Cardiac death is defined as death resulting from an acute myocardial infarction (MI), sudden cardiac death, stroke, death due to heart failure (HF), death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes; target vessel MI is defined as a MI case with the evidence of myocardial necrosis in the vascular territory of previously treated vessel; clinically driven main branch or side branch TVR is defined as a revascularization procedure with repeated stenting, balloon angioplasty or surgical bypass grafting for restenosed or occluded culprit target vessel.

  12th month after stent implantation

Secondary Outcomes (2)

• major adverse cardiac and cerebrovascular events（MACCE）rate（ the percentage of outcomes including all cause death, stroke, myocardial infarction(MI), and all clinically driven target vessel revascularization(TVR) in each group)

  30 days, 6 months, 12 months, 24 months and 36 months after operation

• The percentage of in-stent restenosis (ISR) assessed by quantitative coronary angiography(QCA) in each group

  12 months after operation

Study Arms (2)

IVUS-guided PCI

In this group, intravascular ultrasound(IVUS) in addition to coronary angiography(CAG) is used to guide percutaneous coronary intervention(PCI) procedure of left main bifurcation lesion.

Device: intravascular ultrasound (IVUS); Other: coronary angiography

CAG-guided PCI

In this group, coronary angiography(CAG) is used to guide percutaneous coronary intervention(PCI) procedure of left main bifurcation lesion.

Other: coronary angiography

Interventions

intravascular ultrasound (IVUS) DEVICE

use IVUS in the procedure

IVUS-guided PCI

coronary angiography OTHER

Coronary angiography is required for all PCI procedure.

CAG-guided PCI; IVUS-guided PCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary left main coronary artery bifurcation lesions will be recruited in this study. The target lesions of patients need to be true coronary artery bifurcation lesions (Medina 1,1,1 or 0,1,1)

You may qualify if:

• Patients with stable or unstable angina pectoris, asymptomatic myocardial ischemia or attack of myocardial infarction \>24 h;
• True bifurcation lesion of left main coronary artery (Medina 1,1,1 or 0,1,1);
• According to coronary angiography, the opening stenosis of the left anterior descending (LAD) and left circumflex (LCX) is more than 50% visually;
• The operator judges that the lesion is suitable for drug eluting stent(DES) implantation;
• Branch vessel diameter ≥2.5 mm by visual inspection;

You may not qualify if:

• Pregnant or lactating women;
• Combined with other diseases, life expectancy \<1 year;
• A surgery is scheduled within 6 months after the operation, and this surgery affects continuous administration of antiplatelet drugs;
• The dual antiplatelet therapy cannot be tolerated;
• Follow - up visits required by the protocol cannot be followed, or the investigators believe that the participation of subjects in the trial will increase the risk;
• Unable to provide written informed consent form, or unable to follow the trial protocol;
• Participate in another clinical trial of coronary interventional device;
• Subjects with myocardial infarction within 24 h of onset of chest pain (including ST segment elevation or non - ST segment elevation);
• Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment;
• Hemoglobin \<9 g/L;
• Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg);
• Severe cardiac insufficiency (LVEF \<30%);
• Heart failure complicated with pulmonary hypertension (mean pulmonary artery pressure(mPAP) ≥25 mmHg,pulmonary capillary wedge pressure (PCWP) \>15 mmHg, and pulmonary vascular resistance (PVR)\>3.0WU);
• Complicated with hypertrophic obstructive cardiomyopathy;
• Re-stenotic bifurcation lesion;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ultrasonography, Interventional

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Junbo Ge

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Qin

CONTACT

+86-21-64041990; qin.qing@zs-hospital.sh.cn

Chenguang Li

CONTACT

+86-21-64041990; li.chenguang@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of Cardiology, Zhongshan hospital, principal investigator, clinical professor

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2023
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share