Last updated: November 10, 2021
Sponsor: Instituto Dante Pazzanese de Cardiologia
Overall Status: Active - Recruiting
Phase
N/A
Condition
Heart Disease
Hypercholesterolemia
Chest Pain
Treatment
N/AClinical Study ID
NCT04531007
4978/2019
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- age >/= 18 years;
- patients who have an intermediate (40-70% diameter stenosis) lesion located in the LMSand a concomitant significant (>/=70% diameter stenosis) in one of the two majordownstream vessels (the LAD or the LCx). The severity of LMS and downstream lesionswill be assessed by visual estimation of the coronary angiography;
- need of complementary diagnostic work up to ascertain the functional/physiologicalsignificance of the LMS lesion, that is not possible from the analysis of angiographicimages only:
- Intermediate severity of LMS lesion, or angiographic ambiguity;
- Impossibility to conclusively associate the LMS lesion with the patient'ssymptoms/clinical presentation due to confounders introduced by the significantdownstream lesion;
- Impossibility to conclusively determine the severity and functional/physiologicalsignificance of the LMS lesion solely by the visual analysis of the coronaryangiography;
- Impossibility to conclusively determine the relative contribution of the LMSlesion to the ischemic burden determined by non-invasive functional tests due tothe 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 bythe diseased vessels);
- Reduced FFR/iFR values indicative of myocardial ischemia with significantpressure gradient across the downstream lesion;
- Acute coronary syndrome without ST elevation or stabilized (>7 days) acutemyocardial 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 ofdual antiplatelet therapy for at least 6 months.
Exclusion
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 circulationfrom the left coronary;
- Prior coronary artery bypass graft with at least on patent graft to any vessel of theleft 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 withthe physiology wire and/or intravascular imaging catheter is anticipated
Study Design
Total Participants: 53
Study Start date:
June 01, 2020
Estimated Completion Date:
December 30, 2022
Study Description
Connect with a study center
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909
BrazilActive - Recruiting
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