Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272643
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-02-01
Brief Title:
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Sponsor:
Fundación EPIC
Organization:
Fundación EPIC
Study Overview
Official Title:
Comparison Between Optical Coherence Tomography and Intravascular Ultrasound for Intermediate Left Main Coronary Artery Lesions
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPERATRIZ
Brief Summary:
Significant coronary disease of the left main coronary artery LMCA is found in 4-5 of all coronary angiography procedures Classically it has been determined that a significant angiographic stenosis should reach at least 50 of the vessel diameter by visual estimation which corresponds to 75 of the vessel area However angiography has a number of limitations inherent to the technique and location of stenosis and other techniques are therefore available for evaluation Intracoronary ultrasound IVUS deserves together with the pressure guidewire special consideration in determining the severity assessment anatomical and functional of lesions in this location Using IVUS the most commonly used cut-off value is 6 mm2 in ambiguous lesions of the LMCA a MLA 6 mm2 would indicate no revascularisation a MLA 45-5 mm2 would indicate revascularisation and MLA values between 45-5 and 6 mm2 would make it advisable to use FRFiFR to decide Optical coherence tomography OCT is another intracoronary imaging modality with greater resolution and significant differences from IVUS no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions Due to the differences in imaging with both techniques the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT The objective is to compare the minimal luminal area by IVUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT
Detailed Description:
Significant coronary disease of the left main coronary artery LMCA is found in 4-5 of all coronary angiography procedures It is a particularly important site since it supplies up to 75 of myocardial blood supply and damage at this level thus implies a large amount of left ventricular myocardium at risk with a mortality rate close to 40 at 3 years if revascularisation is not performed
Anatomically it has a number of particularities compared to the rest of the coronary arteries such as its larger diameter 505 mm and variable length 10553 mm a composition particularly at the aorto-ostial level more similar to the aorta than to the coronary arteries and in up to 20-30 of the population there is also a division between the anterior descending artery LAD and the circumflex artery LCx of a third branch called the ramus intermedius or bisector branch
Classically it has been determined that a significant angiographic stenosis should reach at least 50 of the vessel diameter by visual estimation which corresponds to 75 of the vessel area However angiography has a number of limitations inherent to the technique and location of stenosis and other techniques are therefore available for evaluation Intracoronary ultrasound ICUS or IVUS deserves together with the pressure guidewire special consideration in determining the severity assessment anatomical and functional of lesions in this location
Several ICUV studies have attempted to find a minimum luminal area MLA as the cut-off point ranging from 45-75 mm2 to decide whether to perform revascularisation or not However the most commonly used cut-off value is 6 mm2 for various reasons First it is correlated with functionally significant values using pressure guidewire Second the linear law is applied assuming the fractal nature of the vasculature and a cut-off value of 3 mm2 for the LMCA branches Finally it has been validated by the prospective LITRE study with clinical results at 2 years of follow-up Other studies in Asian population have proposed lower cut-off values 45 mm2 However this population has different body size and therefore smaller LMCA size the study has lower sensitivity 14 of patients with area 45 mm2 had positive pressure guidewire and clinical validation is not presented unlike the LITRE study
In addition to its value in diagnosis use of ICUSE allows for optimisation of percutaneous coronary intervention PCI if necessary with decreased events as compared to angiography Therefore current clinical practice guidelines consider the use of IVUS to stratify the severity of all LMCA lesions as an indication IIa B In turn it has been proposed to integrate the use of ICUS and pressure guidewire in the assessment of doubtful LMCA lesions Thus in ambiguous lesions of the LMCA a MLA 6 mm2 would indicate no revascularisation a MLA 45-5 mm2 would indicate revascularisation and MLA values between 45-5 and 6 mm2 would make it advisable to use FRFiFR to decide
Optical coherence tomography OCT is another intracoronary imaging modality with greater resolution and significant differences from ICUS It is an expanding technique However its usefulness in LMCA is somewhat more limited mainly due to the difficult technique of complete filling with contrast and the native area of the ostial segments Another disadvantage of its use in LMCA is its limited penetration depth 2-3 mm compared to ICUS 4-8 mm and since the LMCA usually has diameters of 35-45 mm inadequate assessment may occur In addition no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions On the other hand because of the differences in imaging with both techniques the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT There are however some correlation studies between ICUS and OCT both in vivo and in vitro but not specifically in LMCA In all these studies it has been shown that ICUS consistently overestimates OCT measurement by 10 the latter being the closest to the real value The underuse of this technique in the LCMA is justified by the potential technical problems already mentioned and the lack of a validated MLA cut-off point at this level The potential prognostic implication of finding even in patients with functionally nonsignificant lesions vulnerable plaques or thin-cap fibroatheromas TCFAs in OCT has recently been highlighted The objective is to compare the minimal luminal area by ICUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT
Anatomically it has a number of particularities compared to the rest of the coronary arteries such as its larger diameter 505 mm and variable length 10553 mm a composition particularly at the aorto-ostial level more similar to the aorta than to the coronary arteries and in up to 20-30 of the population there is also a division between the anterior descending artery LAD and the circumflex artery LCx of a third branch called the ramus intermedius or bisector branch
Classically it has been determined that a significant angiographic stenosis should reach at least 50 of the vessel diameter by visual estimation which corresponds to 75 of the vessel area However angiography has a number of limitations inherent to the technique and location of stenosis and other techniques are therefore available for evaluation Intracoronary ultrasound ICUS or IVUS deserves together with the pressure guidewire special consideration in determining the severity assessment anatomical and functional of lesions in this location
Several ICUV studies have attempted to find a minimum luminal area MLA as the cut-off point ranging from 45-75 mm2 to decide whether to perform revascularisation or not However the most commonly used cut-off value is 6 mm2 for various reasons First it is correlated with functionally significant values using pressure guidewire Second the linear law is applied assuming the fractal nature of the vasculature and a cut-off value of 3 mm2 for the LMCA branches Finally it has been validated by the prospective LITRE study with clinical results at 2 years of follow-up Other studies in Asian population have proposed lower cut-off values 45 mm2 However this population has different body size and therefore smaller LMCA size the study has lower sensitivity 14 of patients with area 45 mm2 had positive pressure guidewire and clinical validation is not presented unlike the LITRE study
In addition to its value in diagnosis use of ICUSE allows for optimisation of percutaneous coronary intervention PCI if necessary with decreased events as compared to angiography Therefore current clinical practice guidelines consider the use of IVUS to stratify the severity of all LMCA lesions as an indication IIa B In turn it has been proposed to integrate the use of ICUS and pressure guidewire in the assessment of doubtful LMCA lesions Thus in ambiguous lesions of the LMCA a MLA 6 mm2 would indicate no revascularisation a MLA 45-5 mm2 would indicate revascularisation and MLA values between 45-5 and 6 mm2 would make it advisable to use FRFiFR to decide
Optical coherence tomography OCT is another intracoronary imaging modality with greater resolution and significant differences from ICUS It is an expanding technique However its usefulness in LMCA is somewhat more limited mainly due to the difficult technique of complete filling with contrast and the native area of the ostial segments Another disadvantage of its use in LMCA is its limited penetration depth 2-3 mm compared to ICUS 4-8 mm and since the LMCA usually has diameters of 35-45 mm inadequate assessment may occur In addition no MLA cut-off point with OCT has been demonstrated for the management of LMCA lesions On the other hand because of the differences in imaging with both techniques the thresholds established as cut-off points in IVUS cannot be extrapolated to OCT There are however some correlation studies between ICUS and OCT both in vivo and in vitro but not specifically in LMCA In all these studies it has been shown that ICUS consistently overestimates OCT measurement by 10 the latter being the closest to the real value The underuse of this technique in the LCMA is justified by the potential technical problems already mentioned and the lack of a validated MLA cut-off point at this level The potential prognostic implication of finding even in patients with functionally nonsignificant lesions vulnerable plaques or thin-cap fibroatheromas TCFAs in OCT has recently been highlighted The objective is to compare the minimal luminal area by ICUS and OCT of angiographically intermediate LCMA lesions and to assess the prognostic value of TCFA assessed by OCT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None