Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Imaging and Physiology for Intermediate Left Main Stem Stenosis (VIP-LMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531007
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Daniel Chamié, Instituto Dante Pazzanese de Cardiologia

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Left Main Diagnostic Test: iFR/ FFR/ IVUS/ OCT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of Intravascular Imaging and Physiology for Intermediate Left Main Stem Stenosis With Downstream Coronary Lesions
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intermediate LMS stenosis
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.
Diagnostic Test: iFR/ FFR/ IVUS/ OCT
intermediate lesion evaluation with intracoronary physiology and imaging




Primary Outcome Measures :
  1. 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)

  2. 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)


Secondary Outcome Measures :
  1. 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 ]
    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;

  2. 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 ]
    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;

  3. Agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue. [ Time Frame: diagnostic procedure ]
    Verify the agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.

  4. 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 ]
    Diagnostic accuracy of the minimum lumen area in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis

  5. 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 ]
    Diagnostic accuracy of the minimum lumen diameter in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis

  6. 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 ]
    Diagnostic accuracy of the percent diameter stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis

  7. 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 ]
    Diagnostic accuracy of the percent area stenosis in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis

  8. Accuracy of lesion length determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis [ Time Frame: diagnostic procedure ]
    Diagnostic accuracy of lesion length in the LMS by IVUS and OCT to predict iFRtrue and FFRtrue of the LMS stenosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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;
    • 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.

Exclusion Criteria:

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;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531007


Contacts
Layout table for location contacts
Contact: Daniel Chamie, MD, PhD + 55 11 50856345 daniel.chamie@gmail.com

Locations
Layout table for location information
Brazil
Instituto Dante Pazzanese de Cardiologia Recruiting
São Paulo, Brazil, 04012-909
Contact: Daniel Chamie, MD, PhD    + 55 11 50856345    daniel.chamie@gmail.com   
Sponsors and Collaborators
Instituto Dante Pazzanese de Cardiologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Layout table for investigator information
Principal Investigator: Daniel Chamie, MD, PhD Instituto Dante Pazzanese de Cardiologia
Study Chair: Fausto Feres, MD, PhD Instituto Dante Pazzanese de Cardiologia
Layout table for additonal information
Responsible Party: Daniel Chamié, Principal Investigator, Instituto Dante Pazzanese de Cardiologia
ClinicalTrials.gov Identifier: NCT04531007    
Other Study ID Numbers: 4978/2019
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Chamié, Instituto Dante Pazzanese de Cardiologia:
Left Main Coronary Artery (LMCA)
FFR
iFR
OCT
IVUS
intracoronary imaging
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases