Imaging and Physiology for Intermediate Left Main Stem Stenosis

NCT04531007 | Unknown DMC

• 1 other identifier: 4978/2019
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease Left Main

Keywords

Left Main Coronary Artery (LMCA); FFR; iFR; OCT; IVUS; intracoronary imaging

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  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

  diagnostic procedure

• Accuracy of iFRpred-contra and FFRpred-contra before PCI of the downstream lesion in predicting the functional significance of LMS stenosis

  diagnostic procedure

• Agreement of the iFRcontra and FFRcontra after PCI of the downstream stenosis with the iFRtrue and FFRtrue.

  diagnostic procedure

• Accuracy of minimum lumen area determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis

  diagnostic procedure

• Accuracy of minimum lumen diameter determined by IVUS and OCT in the LMS to predict the functional significance of LMS stenosis

  diagnostic procedure

Study Arms (1)

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.

Diagnostic Test: iFR/ FFR/ IVUS/ OCT

Interventions

iFR/ FFR/ IVUS/ OCT DIAGNOSTIC_TEST

intermediate lesion evaluation with intracoronary physiology and imaging

Intermediate LMS stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, 04012-909, Brazil

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Daniel Chamie, MD, PhD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

• Fausto Feres, MD, PhD

  Instituto Dante Pazzanese de Cardiologia

  STUDY CHAIR

Central Study Contacts

Daniel Chamie, MD, PhD

CONTACT

+ 55 11 50856345; daniel.chamie@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: August 28, 2020
• Study Start: June 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)