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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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