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WE REMAIN EBC
Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)
Sponsor study identifier
observational
1,500
0 countries
N/A
Study Start
September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The slowly accruing evidence on the treatment of patients with left main coronary artery (LMCA) disease drove evolution in guidelines, that currently establish equivalent safety and efficacy for percutaneous coronary intervention (PCI) as compared to surgery, with a class of recommendation that is subjected to the extension and complexity of concomitant coronary artery disease, as assessed by the SYNTAX score. The severity of LMCA disease, although extremely relevant due to the extent of the supplied myocardium, is often difficult to assess with traditional angiography, due to lack of appropriate angiographic views, absence of a true "reference" segment, interaction with the intubating catheter. Intravascular techniques with either imaging or functional assessment have been variously tested, although with a disturbing rate of discordant results; moreover, they are frequently underused for a number of reasons, including the additional time needed to assess both left anterior descending (LAD) and left circumflex (LCx) arteries, technical challenges, costs and the small risk associated with maneuvering such devices. Fractional flow reserve (FFR) measured from the coronary angiogram (FFRangio) alone recently documented a high diagnostic accuracy compared with pressure-wire derived FFR. As for the anatomical localization, the majority of LMCA lesions occur at the bifurcation, where PCI results are less favourable. The distal LMCA differs from the other bifurcations in several characteristics: a) a notable mismatch between the LMCA and the left anterior descending (LAD) artery, hampering the selection of an adequately sized stent, b) the presence of a trifurcation, with a large ramus arising from LMCA in about 10% of cases, c) the presence of left or co-dominant circulation, with the LMCA supplying all or nearly all left ventricular myocardium in about 15% of cases. Therefore, although the European Bifurcation Club (EBC) recommends a provisional side branch approach in most cases of distal LMCA disease, the threshold for placing a second stent in the side branch may be lower in lesions located on LM bifurcation compared with non-LMCA bifurcations. As for double stenting, the evidence is controversial and a consensus is lacking. Moreover, the optimal treatment of patients with LM trifurcations is still undefined. The aim of this study is therefore to determine the optimal strategy for the treatment of LM bifurcated lesions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2020
Actual (reported)March 25, 2020
Actual (reported)September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Major adverse cardiac events (MACE)
The composite of: death from any cause, myocardial infarction (MI), stent thrombosis (ST), defined as definite, probable or possible following the Academic Research Consortium.
12 months
Death
12 months
MI
12 months
ST
12 months
In-hospital MACE
12 Months
Target Vessel Revascularization (TVR)
12 Months
PCI on left main coronary stenosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with a diagnosis of documented silent ischemia, stable angina, or ACS, undergoing PCI with single or multiple DES for the treatment of lesion located at LM coronary bifurcation and defined as a diameter stenosis of ≥50% by visual estimation.
Zimarino M, Briguori C, Amat-Santos IJ, Radico F, Barbato E, Chieffo A, Cirillo P, Costa RA, Erglis A, Gamra H, Gil RJ, Kanic V, Kedev SA, Maddestra N, Nakamura S, Pellicano M, Petrov I, Strozzi M, Tesorio T, Vukcevic V, De Caterina R, Stankovic G; EuroBifurcation Club. Mid-term outcomes after percutaneous interventions in coronary bifurcations. Int J Cardiol. 2019 May 15;283:78-83. doi: 10.1016/j.ijcard.2018.11.139. Epub 2018 Dec 2.
Lassen JF, Holm NR, Banning A, Burzotta F, Lefevre T, Chieffo A, Hildick-Smith D, Louvard Y, Stankovic G. Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club. EuroIntervention. 2016 May 17;12(1):38-46. doi: 10.4244/EIJV12I1A7.
Marco Zimarino, MD, PhD
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
September 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 30, 2021
Contact the study team to confirm eligibility.
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 27, 2020
Record last verified: 2020-03
Case Report Forms (CRF) will be shared among partecipating centers
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Source: ClinicalTrials.gov.
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