ClinConnect ClinConnect Logo
Search / Trial NCT04531007

Imaging and Physiology for Intermediate Left Main Stem Stenosis

Launched by INSTITUTO DANTE PAZZANESE DE CARDIOLOGIA · Aug 27, 2020

Trial Information

Current as of September 13, 2025

Unknown status

Keywords

Left Main Coronary Artery (Lmca) Ffr I Fr Oct Ivus Intracoronary Imaging

ClinConnect Summary

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 infl...

Gender

ALL

Eligibility 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

About Instituto Dante Pazzanese De Cardiologia

Instituto Dante Pazzanese de Cardiologia is a leading clinical research institution based in Brazil, dedicated to advancing cardiovascular medicine through innovative research and clinical trials. Renowned for its commitment to improving patient outcomes, the institute specializes in a wide array of cardiovascular conditions and interventions. With a multidisciplinary team of experts, state-of-the-art facilities, and a robust network of collaboration, Instituto Dante Pazzanese de Cardiologia plays a pivotal role in contributing to the scientific community and enhancing the understanding of heart diseases, ultimately striving to translate research findings into effective clinical practices.

Locations

São Paulo, Brazil

Patients applied

0 patients applied

Trial Officials

Daniel Chamie, MD, PhD

Principal Investigator

Instituto Dante Pazzanese de Cardiologia

Fausto Feres, MD, PhD

Study Chair

Instituto Dante Pazzanese de Cardiologia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials