Coronary Artery DiseaseInfiniteNCT04072003
IVUS VS CAG Guided PCI for Patients With LMB Lesion
An observational study of Coronary Artery Disease and Left Main Coronary Artery Disease, run by Shanghai Zhongshan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Left Main Coronary Artery Disease
- What is being tested?
- intravascular ultrasound (IVUS) and coronary angiography
- Type of treatment
- Medical device
- How many people
- 616 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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).
Read the 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.
- Being tested
- intravascular ultrasound (IVUS), coronary angiography
- Keywords
- Left main, bifurcation, IVUS,PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravascular ultrasound (IVUS)Device
use IVUS in the procedure
coronary angiographyOther
Coronary angiography is required for all PCI procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
TVR is defined as a revascularization procedure with repeated stenting, balloon angioplasty or surgical bypass grafting for restenosed or occluded culprit target vessel.
Measured: 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
ISR is defined as a >50% stenosis of a previously stented segment as judged by QCA after coronary angiography
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
- Investigators
- Junbo Ge, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072003
- Sponsor's protocol ID
- B2018246
- Acronym
- Infinite
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Whether to share the data will be decided by the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound(IVUS) vs Angiography Guided Percutaneous Coronary Intervention(PCI) for Patients With Left Main Bifurcation Lesion
- ClinicalTrials.gov ID
- NCT04072003
- Acronym / sponsor ID
- Infinite / B2018246
- Keywords
- Left main, bifurcation, IVUS,PCI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided PCI | – | Device: intravascular ultrasound (IVUS), Other: coronary angiographyIn 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. |
| CAG-guided PCI | – | Other: coronary angiographyIn this group, coronary angiography(CAG) is used to guide percutaneous coronary intervention(PCI) procedure of left main bifurcation lesion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravascular ultrasound (IVUS)use IVUS in the procedure | Device | IVUS-guided PCI |
| coronary angiographyCoronary angiography is required for all PCI procedure. | Other | CAG-guided PCI, IVUS-guided PCI |
Primary outcome
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.
2 secondary outcomes
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
The percentage of in-stent restenosis (ISR) assessed by quantitative coronary angiography(QCA) in each group
Time frame: 12 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No. Whether to share the data will be decided by the principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junbo Ge principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Left Main Coronary Artery Disease, run by Shanghai Zhongshan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Qin (+86-21-64041990 ext. 5111, qin.qing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.