Acute Coronary SyndromeNCT02843633

LEADERS FREE II: BioFreedom™ Pivotal Study

A study testing BioFreedom™ Drug Coated Coronary Stent System and Antiplatelet Drug in people with Acute Coronary Syndrome and High Bleeding Risk, run by Biosensors Europe SA at 66 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients. Read more about this study

Who is it for?: Any age
Conditions the study is for: Acute Coronary Syndrome, High Bleeding Risk
What is being tested?: BioFreedom™ Drug Coated Coronary Stent System and Antiplatelet Drug
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,203 participants
Where: 66 sitesin 7 countries
Study dates: 14 Feb 2017to Mar 2021
Phase: Interventional
Are there results?: Not yet: the study is under way

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or more of the following:
Adjunctive oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)
Any prior intracerebral bleed

Show all 15Show fewer

Any stroke in the last 12 months
Hospital admission for bleeding during the prior 12 months
Non skin cancer diagnosed or treated < 3 years, with a perceived increased risk for bleeding
Planned daily Nonsteroidal anti-inflammatory drugs (NSAID) (other than aspirin) or steroids for >30 days after PCI
Planned surgery that would require interruption of DAPT (within next 6 months)
Renal failure defined as: Creatinine clearance <40 ml/min
Thrombocytopenia (PLT <100,000/mm3)
Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
Expected non-compliance to prolonged DAPT for other medical reasons

Who cannot join

Pregnant and breastfeeding women
Patients expected not to comply with 1 month DAPT
Patients requiring a planned staged PCI procedure more than one week after the index procedure
Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
Active bleeding at the time of inclusion
Reference vessel diameter <2.25 - >4.0mm

Show all 13Show fewer

Cardiogenic shock
Compliance with long-term single anti-platelet therapy unlikely
A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, zinc, Biolimus A9™ or a sensitivity to contrast media, which cannot be adequately pre-medicated
PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
Participation in another clinical trial (12 months after index procedure)
Patients with a life expectancy of < 12 months
Patients under judicial protection, tutorship or curatorship (for France only)

Trial locations and contacts

66 sites in 7 countries.

Country

City, postcode or hospital

66 sites in 7 countries

United States39 sites

AnMed Health
Anderson, South Carolina, 29621
McLaren Bay Region
Bay City, Michigan, 48708
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712
University of Buffalo
Buffalo, New York, 14203
Lahey Clinic
Burlington, Massachusetts, 01805
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Chattanooga Heart Institute
Chattanooga, Tennessee, 37404
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
Missouri Cardiovascular Specialists, LLP
Columbia, Missouri, 65201
North Georgia Heart Foundation
Gainesville, Georgia, 30501
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Penn State - Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Tri-Lakes Research
Hot Springs, Arkansas, 71901
Houston Methodist Hospital
Houston, Texas, 77030
Heart Center Research, LLC
Huntsville, Alabama, 35801
St. Vincent Heart Center
Indianapolis, Indiana, 46290
University of Florida Jacksonville
Jacksonville, Florida, 32209
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Scripps Health
La Jolla, California, 92037
University of California San Diego
La Jolla, California, 92037
Jewish and St. Mary's Hospital
Louisville, Kentucky, 40202
MidMichigan Medical Center Midland
Midland, Michigan, 48670
Weill Cornell Medical College-New York Presbyterian
New York, New York, 10021
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Rhode Island Hospital
Providence, Rhode Island, 02903
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
Black Hills Cardiovascular Research
Rapid City, South Dakota, 57701
Berks Cardiologists, Ltd.
Reading, Pennsylvania, 19610
Carilion Clinic
Roanoke, Virginia, 24014
William Beaumont Hospital
Royal Oak, Michigan, 48073
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102
Velella Research
Sarasota, Florida, 34239
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308
Providence Health Center
Waco, Texas, 76712
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, 17043
Genesis Healthcare System
Zanesville, Ohio, 43701

Other trials in United States

Canada11 sites

Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Centre Hospitalier de l'université de Montréal
Montreal, Quebec, H2W 1T8
Fraser Clinical Trials Inc.
New Westminster, British Columbia, V3L 3W4
The University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Quebec, G1V 4G5
CIUSSS de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2

Other trials in Canada

France8 sites

Clinique Axium
Aix-en-Provence, 13097
Service de Cardiologie Interventionnelle - Pôle Santé République
Clermont-Ferrand, 63050
Clinique de Fontaine
Fontaine-lès-Dijon, 21121
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, 38000
Hôpital Privé Jacques Cartier ICPS
Massy, 91300
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Clinique Saint Hilaire
Rouen, 76000
CHU Toulouse Rangeuil
Toulouse

Other trials in France

United Kingdom3 sites

Royal Bournemouth Hospital, Dorset Heart Centre
Bournemouth
Craigavon Cardiac Centre
Craigavon, BT63 5QQ
Golden Jubilee National Hospital
Glasgow, G81 4DY

Other trials in United Kingdom

Germany2 sites

Segeberger Kliniken GmbH
Bad Segeberg
Herzzentrum Leipzig GmbH
Leipzig, 04289

Other trials in Germany

Italy2 sites

Grande Ospedale Metropolitano Niguarda
Milan, 20162
Azienda Ospedaliera San Camillo Forlanini
Rome, 00152

Other trials in Italy

Denmark1 site

Rigshospitalet Copenhagen University Hospital
Copenhagen, 2100

Other trials in Denmark

About this study

Official title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

Read the detailed description

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Conditions: Acute Coronary Syndrome, High Bleeding Risk
Being tested: BioFreedom™ Drug Coated Coronary Stent System, Antiplatelet Drug
Keywords: Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug Coated Stent, Drug Eluting Stent
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BioFreedom™ Drug Coated Coronary Stent SystemDevice
Also called Coronary Angioplasty
a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
Antiplatelet DrugDrug
Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice

Study groups in NCT02843633
Study group	Role	What they receive
BioFreedom™ Drug Coated Stent	Experimental	Not described Receives: Device: BioFreedom™ Drug Coated Coronary Stent System; Drug: Antiplatelet Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

The composite of cardiac death and myocardial infarction at twelve months
Measured: 12 months
The incidence of clinically driven target lesion revascularization at twelve months
Measured: 12 months

Secondary outcomes (12)

The composite of cardiac death and myocardial infarction
Measured: 1, 2, and 6 months and 2 and 3 years
The incidence of clinically driven target lesion revascularization
Measured: 1, 2, and 6 months and 2 and 3 years
The composite of cardiac death, myocardial infarction and stent thrombosis
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Bleeding per Bleeding Academic Research Consortium (BARC) Criteria
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Cardiac Death
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Myocardial Infarction
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Stent Thrombosis per Academic Research Consortium (ARC) Definition
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Urgent target lesion revascularization
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Clinically driven target lesion revascularization at time points other than primary endpoint
Measured: followed for all target lesion revascularizations, up to 3 years
Clinically driven target vessel revascularization
Measured: 1, 2, and 6 months and 1, 2, and 3 years
All cause mortality
Measured: 1, 2, and 6 months and 1, 2, and 3 years
Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter
Measured: 1, 2, and 6 months and 1, 2, and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 2017Mar 2021

First posted26 Jul 2016 (estimated)
Study start14 Feb 2017
Primary completion11 Oct 2018
Study completionMar 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 Acute Coronary SyndromeStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1,203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02843633
Sponsor's protocol ID: 16US01
Status last verified: Feb 2021
First submitted: 15 Jul 2016
Last updated: 3 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint

Publications

Eberli FR, Oldroyd KG, Urban P, Krucoff MW, Morice MC, Tanguay JF, Leon MB, Brunel P, Maillard L, Lipiecki J, Cook S, Berland J, Hovasse T, Carrie D, Schutte D, Sadozai Slama S, Garot P. Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years. Open Heart. 2024 Jun 18;11(1):e002679. doi: 10.1136/openhrt-2024-002679.
PubMed 38890129
Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
PubMed 38626080
Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.
PubMed 32432718

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding
ClinicalTrials.gov ID: NCT02843633
Acronym / sponsor ID: 16US01
Conditions: Acute Coronary Syndrome, High Bleeding Risk
Keywords: Acute Coronary Syndrome, Percutaneous Coronary Intervention, Drug Coated Stent, Drug Eluting Stent
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 1,203 participants (actual)
Lead sponsor: Biosensors Europe SAIndustry (pharma, biotech, devices)
Study start: 14 Feb 2017 (actual)
Primary completion: 11 Oct 2018 (actual)
Study completion: Mar 2021 (estimated)
First posted: 26 Jul 2016 (estimated)
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.

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

Detailed description

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BioFreedom™ Drug Coated Stent	Experimental	Device: BioFreedom™ Drug Coated Coronary Stent System, Drug: Antiplatelet Drug

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (15 listed)

Any indication for percutaneous coronary intervention with stent placement (PCI-S) in patients deemed at high risk for bleeding and candidates for 1 month dual anti-platelet therapy (DAPT). This includes candidates with stable angina, silent ischemia, acute coronary syndrome (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.
Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or more of the following:
Adjunctive oral anticoagulation treatment planned to continue after PCI
Age ≥ 75 years old
Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to the index procedure)

Key exclusion criteria (13 listed)

Pregnant and breastfeeding women
Patients expected not to comply with 1 month DAPT
Patients requiring a planned staged PCI procedure more than one week after the index procedure
Procedure planned to require non-study stents, or stand-alone plain old balloon angioplasty (POBA) or stand-alone atherectomy
Active bleeding at the time of inclusion

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
BioFreedom™ Drug Coated Coronary Stent SystemAlso: Coronary Angioplastya non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis	Device	BioFreedom™ Drug Coated Stent
Antiplatelet DrugDual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice	Drug	BioFreedom™ Drug Coated Stent

Primary outcome

The composite of cardiac death and myocardial infarction at twelve months
Time frame: 12 months
The incidence of clinically driven target lesion revascularization at twelve months
Time frame: 12 months

12 secondary outcomes

The composite of cardiac death and myocardial infarction
Time frame: 1, 2, and 6 months and 2 and 3 years
The incidence of clinically driven target lesion revascularization
Time frame: 1, 2, and 6 months and 2 and 3 years
The composite of cardiac death, myocardial infarction and stent thrombosis
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Bleeding per Bleeding Academic Research Consortium (BARC) Criteria
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Cardiac Death
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Myocardial Infarction
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Stent Thrombosis per Academic Research Consortium (ARC) Definition
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Urgent target lesion revascularization
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Clinically driven target lesion revascularization at time points other than primary endpoint
Time frame: followed for all target lesion revascularizations, up to 3 years
Clinically driven target vessel revascularization
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
All cause mortality
Time frame: 1, 2, and 6 months and 1, 2, and 3 years
Primary endpoints, in patients with at least 1 lesion treated with a trial stent of 3mm or less in nominal diameter
Time frame: 1, 2, and 6 months and 1, 2, and 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Derived from this study: PubMed 38890129Eberli FR, Oldroyd KG, Urban P, Krucoff MW, Morice MC, Tanguay JF, Leon MB, Brunel P, Maillard L, Lipiecki J, Cook S, Berland J, Hovasse T, Carrie D, Schutte D, Sadozai Slama S, Garot P. Clinical outcomes with thin versus thick strut polymer-free biolimus-coated stents at 3 years. Open Heart. 2024 Jun 18;11(1):e002679. doi: 10.1136/openhrt-2024-002679.
Derived from this study: PubMed 38626080Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.
Derived from this study: PubMed 32432718Mehran R, Chandrasekhar J, Urban P, Lang IM, Windhoevel U, Spaulding C, Copt S, Stoll HP, Morice MC; LEADERS FREE Investigators. Sex-Based Outcomes in Patients With a High Bleeding Risk After Percutaneous Coronary Intervention and 1-Month Dual Antiplatelet Therapy: A Secondary Analysis of the LEADERS FREE Randomized Clinical Trial. JAMA Cardiol. 2020 Aug 1;5(8):939-947. doi: 10.1001/jamacardio.2020.0285.
Individual participant dataSharing planned: Yes. The emphasis in all scientific publications and presentations will be placed on the 1-year endpoint

Related trials for Acute Coronary Syndrome

Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
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Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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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.

Martin Leon study chair

Cardiovascular Research Foundation, New York

Mitchell Krucoff principal investigator

Duke University

Philip Urban principal investigator

Hôpital de la Tour

66 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in United States, Canada, France, United Kingdom, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The composite of cardiac death and myocardial infarction at twelve months (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT02843633, 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 3 Feb 2021.