Coronary ArteriosclerosisWE REMAIN EBCNCT04321473
Registry on Left Main Coronary Artery Bifurcation Percutaneous Intervention
An observational study of Coronary Arteriosclerosis and Left Main Coronary Artery Disease, run by G. d'Annunzio University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Arteriosclerosis, Left Main Coronary Artery Disease
- What is being tested?
- PCI on left main
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 30 Sep 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients ≥18 years of age with a diagnosis of documented silent ischemia, stable angina, or acute coronary syndrome (ACS).
- PCI with single or multiple drug-eluting stent (DES) for the treatment of lesion located at LMCA bifurcation and defined as a diameter stenosis of ≥50% by visual estimation.
Who cannot join
- Patients who cannot give informed consent or have a life expectancy of ≤12 months;
- Pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
- Contraindication or suspected intolerance to anticoagulant (heparin, bivalirudin) or oral antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)
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.
Read more
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.
Read the detailed description
PCI access site and technique will be left at the operator's discretion, as well as antithrombotic management.
No limitation will be applied for the technique of PCI. As regards data collection and endpoints, Case Report Form (CRF) will be entered on a web-based platform, where study participants will be able to access and retrieve data at any time during study progress.
In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a 30-day, 6-month, and 1-year telephone interview.
On a center-to-center voluntary basis, pre-PCI and post-PCI angiographic images (made blind regarding patients' identity) will be sent to a study angiographic core-lab for Quantitative Angiography Substudy. The images will be processed using a validated quantitative coronary angiography (QCA) Bifurcation software to assess quantitative data describing bifurcation geometry before and after LMCA PCI. In the Quantitative Angiography Substudy, on exploratory bases, FFRangio data reconstructed by angiographic software will be tested against stenosis LMCA lesion severity and LMCA PCI result.
- Being tested
- PCI on left main
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI on left mainProcedure or surgery
PCI on left main coronary stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (6)
Death
All-cause death and cardiovascular death
Measured: 12 months
MI
Myocardial Infarction
Measured: 12 months
ST
Stent thrombosis (definite, probable or possible)
Measured: 12 months
In-hospital MACE
Composite of death, MI and ST
Measured: 12 Months
Target Vessel Revascularization (TVR)
Target Vessel Revascularization
Measured: 12 Months
Bleeding
The occurrence of major bleeding, as a bleeding defined by the academic research consortium (BARC)- classified as type 3 (a, b or c) or 5 bleeding event
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti, Hospital Clínico Universitario de Valladolid, VZW Cardiovascular Research Center Aalst, Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Clinica Mediterranea, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, San Raffaele University Hospital, Italy, Instituto Dante Pazzanese de Cardiologia, University Medical Centre Maribor, Clinica Di Montevergine, Clinical Hospital Centre Zagreb, Clinical Centre of Serbia, Chiba University, Université Paris-Sud, Hospital Universitario Reina Sofia de Cordoba, Mount Sinai Hospital, New York, Hospital Pablo Tobón Uribe, Pauls Stradins Clinical University Hospital, University Hospital Monastir, Tunis
- Responsible party
- Principal investigator, Marco Zimarino, G. d'Annunzio University
- Investigators
- Marco Zimarino, MD, PhD, Principal investigator, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321473
- Sponsor's protocol ID
- WE_REMAIN_EBC_19
- Acronym
- WE REMAIN EBC
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Case Report Forms (CRF) will be shared among partecipating centers
Publications
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.
PubMed 30528620Lassen 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.
PubMed 27173860Neumann 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.
PubMed 30165437
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Registry on Left Main From the Euro Bifurcation Club (WE REMAIN EBC)
- ClinicalTrials.gov ID
- NCT04321473
- Acronym / sponsor ID
- WE REMAIN EBC / WE_REMAIN_EBC_19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti, Hospital Clínico Universitario de Valladolid, VZW Cardiovascular Research Center Aalst, Federico II University, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Clinica Mediterranea, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, San Raffaele University Hospital, Italy, Instituto Dante Pazzanese de Cardiologia, University Medical Centre Maribor, Clinica Di Montevergine, Clinical Hospital Centre Zagreb, Clinical Centre of Serbia, Chiba University, Université Paris-Sud, Hospital Universitario Reina Sofia de Cordoba, Mount Sinai Hospital, New York, Hospital Pablo Tobón Uribe, Pauls Stradins Clinical University Hospital, University Hospital Monastir, Tunis
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PCI access site and technique will be left at the operator's discretion, as well as antithrombotic management.
No limitation will be applied for the technique of PCI. As regards data collection and endpoints, Case Report Form (CRF) will be entered on a web-based platform, where study participants will be able to access and retrieve data at any time during study progress.
In-hospital outcomes will be recorded; all patients discharged alive will be followed up with a 30-day, 6-month, and 1-year telephone interview.
On a center-to-center voluntary basis, pre-PCI and post-PCI angiographic images (made blind regarding patients' identity) will be sent to a study angiographic core-lab for Quantitative Angiography Substudy. The images will be processed using a validated quantitative coronary angiography (QCA) Bifurcation software to assess quantitative data describing bifurcation geometry before and after LMCA PCI. In the Quantitative Angiography Substudy, on exploratory bases, FFRangio data reconstructed by angiographic software will be tested against stenosis LMCA lesion severity and LMCA PCI result.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- Patients ≥18 years of age with a diagnosis of documented silent ischemia, stable angina, or acute coronary syndrome (ACS).
- PCI with single or multiple drug-eluting stent (DES) for the treatment of lesion located at LMCA bifurcation and defined as a diameter stenosis of ≥50% by visual estimation.
Key exclusion criteria (3 listed)
- Patients who cannot give informed consent or have a life expectancy of ≤12 months;
- Pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant.
- Contraindication or suspected intolerance to anticoagulant (heparin, bivalirudin) or oral antiplatelet therapy (aspirin, clopidogrel, prasugrel, ticagrelor).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI on left mainPCI on left main coronary stenosis | Procedure or surgery | – |
Primary outcome
Major adverse cardiac events (MACE)
Time frame: 12 months
The composite of: death from any cause, myocardial infarction (MI), stent thrombosis (ST), defined as definite, probable or possible following the Academic Research Consortium.
6 secondary outcomes
Death
Time frame: 12 months
MI
Time frame: 12 months
ST
Time frame: 12 months
In-hospital MACE
Time frame: 12 Months
Target Vessel Revascularization (TVR)
Time frame: 12 Months
Bleeding
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 30528620Zimarino 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.
- Background: PubMed 27173860Lassen 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.
- Background: PubMed 30165437Neumann 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.
- Individual participant dataSharing planned: Yes. Case Report Forms (CRF) will be shared among partecipating centers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Zimarino, MD, PhD principal investigator
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arteriosclerosis and Left Main Coronary Artery Disease, run by G. d'Annunzio University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Zimarino, MD, PhD (+39 3476045261, m.zimarino@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321473, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.