Coronary Artery Disease Left MainVIP-LMSNCT04531007
Imaging and Physiology for Intermediate Left Main Stem Stenosis
A study testing iFR/ FFR/ IVUS/ OCT in people with Coronary Artery Disease Left Main, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
Trial summary
The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery (LMCA) stenoses of intermediate severity as determined by coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease Left Main
- What is being tested?
- iFR/ FFR/ IVUS/ OCT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2020to 30 Dec 2022
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >/= 18 years;
- patients who have an intermediate (40-70% diameter stenosis) lesion located in the LMS and a concomitant significant (>/=70% diameter stenosis) in one of the two major downstream vessels (the LAD or the LCx). The severity of LMS and downstream lesions will be assessed by visual estimation of the coronary angiography;
- need of complementary diagnostic work up to ascertain the functional/physiological significance of the LMS lesion, that is not possible from the analysis of angiographic images only:
- Intermediate severity of LMS lesion, or angiographic ambiguity;
- Impossibility to conclusively associate the LMS lesion with the patient's symptoms/clinical presentation due to confounders introduced by the significant downstream lesion;
- Impossibility to conclusively determine the severity and functional/physiological significance of the LMS lesion solely by the visual analysis of the coronary angiography;
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- Impossibility to conclusively determine the relative contribution of the LMS lesion to the ischemic burden determined by non-invasive functional tests due to the presence of a significant downstream lesion;
- Clinical indication for PCI of the downstream lesion located in the LAD or LCx:
- stable angina unresponsive to optimized medical treatment;
- important ischemic burden (> 10% of myocardial mass in territories supplied by the diseased vessels);
- Reduced FFR/iFR values indicative of myocardial ischemia with significant pressure gradient across the downstream lesion;
- Acute coronary syndrome without ST elevation or stabilized (>7 days) acute myocardial infarction;
- Downstream lesion anatomically suited for PCI;
- LMS anatomy suited for PCI, with a low or intermediate SYNTAX score (< 32);
- Lack of contra-indications for second-generation drug-eluting stents and/or use of dual antiplatelet therapy for at least 6 months.
Who cannot join
- Left ventricular ejection fraction £ 40%;
- Renal dysfunction with a glomerular filtration rate £ 45 mL/min;
- Concomitance of right coronary artery occlusion supplied by collateral circulation from the left coronary;
- Prior coronary artery bypass graft with at least on patent graft to any vessel of the left coronary;
- Concomitant significant valvular heart disease;
- The first 7 days of an acute myocardial infarction;
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- Downstream lesion located only in branches from the major downstream vessels (e.g. diagonal branches of LAD or obtuse marginal branches of the LCx);
- Downstream lesions located in the distal segments of LAD or LCx;
- Significant tortuosity of the downstream vessels in which difficulty to navigate with the physiology wire and/or intravascular imaging catheter is anticipated
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909
Daniel Chamie, MD, PhD, + 55 11 50856345, daniel.chamie@gmail.com
About this study
Official title: Validation of Intravascular Imaging and Physiology for Intermediate Left Main Stem Stenosis With Downstream Coronary Lesions
The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery (LMCA) stenoses of intermediate severity as determined by coronary angiography. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements pf LMCA lesions.
Read the detailed description
Accurate characterization of the functional significance of intermediate stenoses located in the left main coronary artery (LMCA) is of central relevance for decisions about the need of myocardial revascularization. However, the physiological assessment of such lesions by means of fractional flow reserve (FFR) measurements are affected by stenoses in the downstream vessels (left anterior descending artery and/or left circumflex artery), which frequently coexist in series with LMCA lesions. More recently introduced, the instantaneous wave-free ratio (iFR) is a resting index that is less influenced by crosstalk between serial lesions and, in theory, could be more accurate for assessment of LMCA stenoses in the presence of downstream disease. Nonetheless, iFR has not been validated for assessment of LMCA lesions. Due to the difficulty in interpreting FFR results, the possibility of characterizing the atheroma type, precisely estimate lesion severity and disease extension and distribution, intravascular imaging [especially intravascular ultrasound (IVUS)] became an attractive alternative to assess LMCA lesions and guide the percutaneous treatment, whenever this strategy is selected. However, most IVUS validations for LMCA stenosis assessment used FFR as the standard comparator, which by itself has limited diagnostic ability in this anatomic scenario.
Thus, the main objective of the current research project is to determine the impact of stenoses in downstream vessels on FFR and iFR measurements of LMCA stenoses of intermediate severity as determined by coronary angiography. The primary endpoint is the change (delta) in FFR and iFR values prior and after percutaneous treatment of downstream stenoses. Assuming a change of 0.04 mmHg between the FFRpredicted and FFRtrue with a standard deviation of 0.04 mmHg, and a change of 0.01 mmHg between iFRpredicted and iFRtrue with a standard deviation of 0.03 mmHg, a total of 53 patients are needed to confirm the mean difference of 0.03 mmHg between iFR and FFR changes before and after treatment of downstream stenoses. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements.
- Conditions
- Coronary Artery Disease Left Main
- Being tested
- iFR/ FFR/ IVUS/ OCT
- Keywords
- Left Main Coronary Artery (LMCA), FFR, iFR, OCT, IVUS, intracoronary imaging
- 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.
iFR/ FFR/ IVUS/ OCTDiagnostic test
intermediate lesion evaluation with intracoronary physiology and imaging
| Study group | Role | What they receive |
|---|---|---|
| Intermediate LMS stenosis | Experimental | Patients with intermediate left main stem stenosis with additional severe downstream lesion will be subject to physiology (FFR and iFR) at multiple sites along the target vessels before and after PCI of the severe lesion located in the downstream vessel. Intravascular imaging (IVUS and OCT) will be performed for additional evaluation of the left main stem stenosis. Receives: Diagnostic Test: iFR/ FFR/ IVUS/ OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis
determine the change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis (iFRtrue - iFRpred and FFRtrue - FFRpred)
Measured: diagnostic procedure
Accuracy of intravascular imaging in predicting functionally signifcant LMS stenosis
establish the diagnostic accuracy of the minimum lumen areas determined by IVUS and OCT in the LMS in comparison with the iFRtrue and FFRtrue)
Measured: diagnostic procedure
Secondary outcomes (8)
Accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Establish the accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion to predict the iFRtue and FFRtrue observed after PCI of the downstream lesion;
Measured: diagnostic procedure
Accuracy of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Establish the ability of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predict the iFRtrue and FFRtrue of the LMS stenosis;
Measured: diagnostic procedure
Agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Verify the agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Measured: diagnostic procedure
Accuracy of minimum lumen area determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the minimum lumen area in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Measured: diagnostic procedure
Accuracy of minimum lumen diameter determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the minimum lumen diameter in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Measured: diagnostic procedure
Accuracy of percent diameter stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the percent diameter stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Measured: diagnostic procedure
Accuracy of percent area stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of the percent area stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Measured: diagnostic procedure
Accuracy of lesion length determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Diagnostic accuracy of lesion length in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis
Measured: diagnostic procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Jun 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease Left MainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Daniel Chamié, Instituto Dante Pazzanese de Cardiologia
- Investigators
- Daniel Chamie, MD, PhD, Principal investigator, Instituto Dante Pazzanese de CardiologiaFausto Feres, MD, PhD, Study chair, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531007
- Sponsor's protocol ID
- 4978/2019
- Acronym
- VIP-LMS
- Status last verified
- Nov 2021
- First submitted
- 26 Jun 2020
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Intravascular Imaging and Physiology for Intermediate Left Main Stem Stenosis With Downstream Coronary Lesions
- ClinicalTrials.gov ID
- NCT04531007
- Acronym / sponsor ID
- VIP-LMS / 4978/2019
- Conditions
- Coronary Artery Disease Left Main
- Keywords
- Left Main Coronary Artery (LMCA), FFR, iFR, OCT, IVUS, intracoronary imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 28 Aug 2020 (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.
The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery (LMCA) stenoses of intermediate severity as determined by coronary angiography. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements pf LMCA lesions.
Detailed description
Accurate characterization of the functional significance of intermediate stenoses located in the left main coronary artery (LMCA) is of central relevance for decisions about the need of myocardial revascularization. However, the physiological assessment of such lesions by means of fractional flow reserve (FFR) measurements are affected by stenoses in the downstream vessels (left anterior descending artery and/or left circumflex artery), which frequently coexist in series with LMCA lesions. More recently introduced, the instantaneous wave-free ratio (iFR) is a resting index that is less influenced by crosstalk between serial lesions and, in theory, could be more accurate for assessment of LMCA stenoses in the presence of downstream disease. Nonetheless, iFR has not been validated for assessment of LMCA lesions. Due to the difficulty in interpreting FFR results, the possibility of characterizing the atheroma type, precisely estimate lesion severity and disease extension and distribution, intravascular imaging [especially intravascular ultrasound (IVUS)] became an attractive alternative to assess LMCA lesions and guide the percutaneous treatment, whenever this strategy is selected. However, most IVUS validations for LMCA stenosis assessment used FFR as the standard comparator, which by itself has limited diagnostic ability in this anatomic scenario.
Thus, the main objective of the current research project is to determine the impact of stenoses in downstream vessels on FFR and iFR measurements of LMCA stenoses of intermediate severity as determined by coronary angiography. The primary endpoint is the change (delta) in FFR and iFR values prior and after percutaneous treatment of downstream stenoses. Assuming a change of 0.04 mmHg between the FFRpredicted and FFRtrue with a standard deviation of 0.04 mmHg, and a change of 0.01 mmHg between iFRpredicted and iFRtrue with a standard deviation of 0.03 mmHg, a total of 53 patients are needed to confirm the mean difference of 0.03 mmHg between iFR and FFR changes before and after treatment of downstream stenoses. Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography (OCT) will also be validated using as the comparator the FFRtrue and iFRtrue measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermediate LMS stenosis | Experimental | Diagnostic Test: iFR/ FFR/ IVUS/ OCTPatients with intermediate left main stem stenosis with additional severe downstream lesion will be subject to physiology (FFR and iFR) at multiple sites along the target vessels before and after PCI of the severe lesion located in the downstream vessel. Intravascular imaging (IVUS and OCT) will be performed for additional evaluation of the left main stem stenosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- age >/= 18 years;
- patients who have an intermediate (40-70% diameter stenosis) lesion located in the LMS and a concomitant significant (>/=70% diameter stenosis) in one of the two major downstream vessels (the LAD or the LCx). The severity of LMS and downstream lesions will be assessed by visual estimation of the coronary angiography;
- need of complementary diagnostic work up to ascertain the functional/physiological significance of the LMS lesion, that is not possible from the analysis of angiographic images only:
- Clinical indication for PCI of the downstream lesion located in the LAD or LCx:
- Downstream lesion anatomically suited for PCI;
Key exclusion criteria (9 listed)
- Left ventricular ejection fraction £ 40%;
- Renal dysfunction with a glomerular filtration rate £ 45 mL/min;
- Concomitance of right coronary artery occlusion supplied by collateral circulation from the left coronary;
- Prior coronary artery bypass graft with at least on patent graft to any vessel of the left coronary;
- Concomitant significant valvular heart disease;
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 |
|---|---|---|
| iFR/ FFR/ IVUS/ OCTintermediate lesion evaluation with intracoronary physiology and imaging | Diagnostic test | Intermediate LMS stenosis |
Primary outcome
Change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis
Time frame: diagnostic procedure
determine the change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis (iFRtrue - iFRpred and FFRtrue - FFRpred)
Accuracy of intravascular imaging in predicting functionally signifcant LMS stenosis
Time frame: diagnostic procedure
establish the diagnostic accuracy of the minimum lumen areas determined by IVUS and OCT in the LMS in comparison with the iFRtrue and FFRtrue)
8 secondary outcomes
Accuracy of pressure changes in the iFR and FFR pullback curves before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Time frame: diagnostic procedure
Accuracy of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predicting the functional significance of LMS stenosis
Time frame: diagnostic procedure
Agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.
Time frame: diagnostic procedure
Accuracy of minimum lumen area determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Time frame: diagnostic procedure
Accuracy of minimum lumen diameter determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Time frame: diagnostic procedure
Accuracy of percent diameter stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Time frame: diagnostic procedure
Accuracy of percent area stenosis determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Time frame: diagnostic procedure
Accuracy of lesion length determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis
Time frame: diagnostic procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Daniel Chamie, MD, PhD principal investigator
Instituto Dante Pazzanese de Cardiologia
Fausto Feres, MD, PhD study chair
Instituto Dante Pazzanese de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iFR/ FFR/ IVUS/ OCT in people with Coronary Artery Disease Left Main, run by Instituto Dante Pazzanese de Cardiologia at 1 site in Brazil.
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 15 inclusion and 9 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 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Daniel Chamie, MD, PhD (+ 55 11 50856345, daniel.chamie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of iFR and FFR values of the LMS stenosis before and after PCI of the significant downstream stenosis (time frame: diagnostic procedure). The study lists 2 primary outcomes in all. 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 11 Nov 2021.