IVUS VS CAG Guided PCI for Patients With LMB Lesion (Infinite)

August 26, 2019 updated by: Junbo Ge, Shanghai Zhongshan Hospital

Intravascular Ultrasound(IVUS) vs Angiography Guided Percutaneous Coronary Intervention(PCI) for Patients With Left Main Bifurcation Lesion

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 1,1,1 or 0,1,1). After angiography, patients will be randomly assigned to intravascular ultrasound(IVUS) - guided and coronary angiography (CAG)- guided groups. The random number of patients will be generated by the central computer random system, and the random will be stratified according to the study sites. In coronary angiography(CAG)-guided group, two-stent technique will be used(the exact two-stent technique used was left to the operator's discretion). In intravascular ultrasound(IVUS)-guided group, minimal lumen area(MLA) in ostium of side branch will be measured by intravascular ultrasound(IVUS). If minimal lumen area(MLA)<4mm2, two-stent technique will be used(the exact two-stent technique used was left to the operator's discretion) and intravascular ultrasound(IVUS) will be repeated at the end of the procedure. If minimal lumen area(MLA) >=4mm2, one-stent technique will be used and intravascular ultrasound(IVUS) will be repeated. If minimal lumen area(MLA) in ostium of side branch is still >=4mm2, the procedure will be ended. If minimal lumen area(MLA) in ostium of side branch become <4mm2, the following interventional strategy will be left to the operator's discretion( balloon inflation, drug-eluting balloon, or switch to two-stent technique). Again, intravascular ultrasound(IVUS) will be repeated at the end of the procedure.

Study Type

Observational

Enrollment (Anticipated)

616

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Combined with other diseases, life expectancy <1 year;
  3. A surgery is scheduled within 6 months after the operation, and this surgery affects continuous administration of antiplatelet drugs;
  4. The dual antiplatelet therapy cannot be tolerated;
  5. 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;
  6. Unable to provide written informed consent form, or unable to follow the trial protocol;
  7. Participate in another clinical trial of coronary interventional device;
  8. Subjects with myocardial infarction within 24 h of onset of chest pain (including ST segment elevation or non - ST segment elevation);
  9. Suffer from renal failure requiring dialysis treatment or is undergoing dialysis treatment;
  10. Hemoglobin <9 g/L;
  11. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg);
  12. Severe cardiac insufficiency (LVEF <30%);
  13. 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);
  14. Complicated with hypertrophic obstructive cardiomyopathy;
  15. Re-stenotic bifurcation lesion;
  16. Severe calcified lesions requiring rotational atherectomy;
  17. Chronic total occlusion lesion without successful recanalization;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
use IVUS in the procedure
Other: coronary angiography
Coronary angiography is required for all PCI procedure.
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
Coronary angiography is required for all PCI procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 12th month after stent implantation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 30 days, 6 months, 12 months, 24 months and 36 months after operation
TVR is defined as a revascularization procedure with repeated stenting, balloon angioplasty or surgical bypass grafting for restenosed or occluded culprit target vessel.
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
Time Frame: 12 months after operation
ISR is defined as a >50% stenosis of a previously stented segment as judged by QCA after coronary angiography
12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2018246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Whether to share the data will be decided by the principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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