Status:
UNKNOWN
IVUS VS CAG Guided PCI for Patients With LMB Lesion
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Coronary Artery Disease
Left Main Coronary Artery Disease
Eligibility:
All Genders
18-80 years
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 percutaneo...
Detailed Description
616 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,...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
- Severe calcified lesions requiring rotational atherectomy;
- Chronic total occlusion lesion without successful recanalization;
Key Trial Info
Start Date :
September 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
616 Patients enrolled
Trial Details
Trial ID
NCT04072003
Start Date
September 1 2019
End Date
September 1 2023
Last Update
August 28 2019
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