PADVISION-VQINCT04204564
VISION and VQI Paclitaxel Safety Analysis
An observational study of PAD, run by University of Vermont Medical Center.
Trial summary
Objectives 1. The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- PAD
- What is being tested?
- pactlitaxel PAD device
- Type of treatment
- Medical device
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2012to 1 Jun 2020
- How long will I take part?
- 4 Years
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients, aged 65 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 10/1/2012 and the latest available CMS dataset (12/31/2016) will be included.
Who may be able to join
- Age ≥ 65 years old
- Date of index procedure is within 10/1/2012 to 12/31/2016
- Symptomatic disease ranging from intermittent claudication to chronic limb-threatening ischemia (including ischemic rest pain and/or tissue loss)
- Elective or urgent procedures
Who cannot join
- Aneurysmal disease of the superficial femoral or popliteal artery
- Treatment for acute limb ischemia
- Treatment of common femoral artery or profunda femoral artery occlusive disease
- Emergency procedures
- PVI and concomitant femoral endarterectomy, suprainguinal or infrainguinal bypass
About this study
Official title: Vascular Implant Surveillance and Interventional Outcomes Network and the Vascular Quality Initiative Paclitaxel Safety Analysis
Objectives
- The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. By linking VQI patients to Medicare claims retrospectively from 2012 to 2016, we will be able to identify additional paclitaxel devices enabling longitudinal follow-up of mortality out to 5 years for paclitaxel-eluting stents and 3 years for paclitaxel-coated balloons.
- To analyze factors associated with mortality, specifically comparing paclitaxel patients surviving vs. paclitaxel patients with mortality. The goal is to identify independent factors predictive of mortality in US pivotal trials and model registry data exposures with sufficient factors to track competing risk paradox and show emulation or not of mortality outcomes with both PTX and PTA exposures.
- To confirm the effectiveness of paclitaxel devices by comparing reintervention for paclitaxel and non-paclitaxel devices. In-hospital mortality from open and percutaneous target vessel revascularization (TVR) will be reported to determine the impact of subsequent revascularizations on survival. Major amputation will be comparted for patients with chronic limb-threatening ischemia.
Read the detailed description
The proposed safety analyses will evaluate two types of paclitaxel-coated interventional devices used to treat PAD and compare patient outcomes with propensity score-matched patients of similar risk who receive non-paclitaxel devices.
The primary outcome will be freedom from all-cause death using propensity-matched survival analysis.
Three principle analyses are planned:
- Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact Admiral, and Philips Spectranetics Stellarex DCB's) as compared with propensity-matched patients treated with plain balloons.
- Paclitaxel delivering DES (Cook Zilver PTX) as compared with propensity-matched cases using bare-metal stents (BMS).
- Patients treated with either Paclitaxel DCB or Paclitaxel DES compared with propensity-matched controls (with DCB patients matched to patients treated with plain balloons, and DES patients matched to patients treated with BMS).
Note that this analysis is planned at the device class level and is not intended to compare early or late mortality between specific devices or brands.
- Conditions
- PAD
- Being tested
- pactlitaxel PAD device
- Keywords
- paclitaxel, drug coated balloon, drug eluting stent, perihpheral vascular intervention, registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pactlitaxel PAD deviceDevice
Also called Medtronic INPact Admiral, Bard Lutonix, Cook Zilver PTX stent
Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel coated balloon angioplasty | Procedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery Receives: Device: pactlitaxel PAD device | |
| plain balloon angioplasty | Procedures with plain balloon angioplasty of the superficial femoral-popliteal artery | |
| paclitaxel eluting stent | Procedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery Receives: Device: pactlitaxel PAD device | |
| bare metal stenting | Procedures with bare metal self expanding stenting of the superficial femoral-popliteal artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality
death from any cause
Measured: 1 year
overall mortality
death from any cause
Measured: 3 years
overall mortality
death from any cause
Measured: 5 years
Secondary outcomes (2)
target vessel revascularization (TVR)
repeat intervention on the SFA-popliteal artery including open or endovascular revascularization
Measured: 1-3-5 years
Major amputation
Major amputation for patients with chronic limb-threatening ischemia
Measured: 1-3-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Oct 2012
- Primary completion31 Dec 2016
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PADStudies 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
- Other
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Medical Device Epidemiology Network (MDEpiNet), Society for Vascular Surgery Patient Safety Organization
- Responsible party
- Principal investigator, Daniel Bertges, MD, University of Vermont Medical Center
- Investigators
- Daniel Bertges, MD, Principal investigator, SVS VQIPhilip Goodney, MD, Study director, SVS VQIArt Sedrakyan, PhD, Study director, Weill Medical College of Cornell UniversityJens Jorgensen, Study chair, SVS PSO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204564
- Sponsor's protocol ID
- 1
- Acronym
- VISION-VQI
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.
PubMed 30561254Columbo JA, Kang R, Hoel AW, Kang J, Leinweber KA, Tauber KS, Hila R, Ramkumar N, Sedrakyan A, Goodney PP. A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg. 2019 Jan;69(1):74-79.e6. doi: 10.1016/j.jvs.2018.03.423. Epub 2018 Jun 15.
PubMed 29914838Schillinger M, Minar E. Past, present and future of femoropopliteal stenting. J Endovasc Ther. 2009 Feb;16 Suppl 1:I147-52. doi: 10.1583/1545-1550-16.16.I-147.
PubMed 19317587Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
PubMed 19859954Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD006767. doi: 10.1002/14651858.CD006767.pub3.
PubMed 24959692Eliason JL, Wainess RM, Proctor MC, Dimick JB, Cowan JA Jr, Upchurch GR Jr, Stanley JC, Henke PK. A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia. Ann Surg. 2003 Sep;238(3):382-9; discussion 389-90. doi: 10.1097/01.sla.0000086663.49670.d1.
PubMed 14501504Earnshaw JJ, Whitman B, Foy C. National Audit of Thrombolysis for Acute Leg Ischemia (NATALI): clinical factors associated with early outcome. J Vasc Surg. 2004 May;39(5):1018-25. doi: 10.1016/j.jvs.2004.01.019.
PubMed 15111854Howard DP, Banerjee A, Fairhead JF, Hands L, Silver LE, Rothwell PM; Oxford Vascular Study. Population-Based Study of Incidence, Risk Factors, Outcome, and Prognosis of Ischemic Peripheral Arterial Events: Implications for Prevention. Circulation. 2015 Nov 10;132(19):1805-15. doi: 10.1161/CIRCULATIONAHA.115.016424. Epub 2015 Sep 8.
PubMed 26350058Baril DT, Ghosh K, Rosen AB. Trends in the incidence, treatment, and outcomes of acute lower extremity ischemia in the United States Medicare population. J Vasc Surg. 2014 Sep;60(3):669-77.e2. doi: 10.1016/j.jvs.2014.03.244. Epub 2014 Apr 24.
PubMed 24768362Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. No abstract available.
PubMed 27851991Oakes D, Feng C. Combining stratified and unstratified log-rank tests in paired survival data. Stat Med. 2010 Jul 20;29(16):1735-45. doi: 10.1002/sim.3921.
PubMed 20572124M Grambsch and TM Therneau, Proportional Hazards Tests and Diagnostics Based on Weighted Residuals, Biometrika 1994, 81(3): 515-526, https://doi.org/10.1093/biomet/81.3.515
Royston P, Parmar MK. Restricted mean survival time: an alternative to the hazard ratio for the design and analysis of randomized trials with a time-to-event outcome. BMC Med Res Methodol. 2013 Dec 7;13:152. doi: 10.1186/1471-2288-13-152.
PubMed 24314264Parzen M, Lipsitz SR. A global goodness-of-fit statistic for Cox regression models. Biometrics. 1999 Jun;55(2):580-4. doi: 10.1111/j.0006-341x.1999.00580.x.
PubMed 11318217Heinze G, Wallisch C, Dunkler D. Variable selection - A review and recommendations for the practicing statistician. Biom J. 2018 May;60(3):431-449. doi: 10.1002/bimj.201700067. Epub 2018 Jan 2.
PubMed 29292533
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Implant Surveillance and Interventional Outcomes Network and the Vascular Quality Initiative Paclitaxel Safety Analysis
- ClinicalTrials.gov ID
- NCT04204564
- Acronym / sponsor ID
- VISION-VQI / 1
- Conditions
- PAD
- Keywords
- paclitaxel, drug coated balloon, drug eluting stent, perihpheral vascular intervention, registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Collaborators
- The Medical Device Epidemiology Network (MDEpiNet), Society for Vascular Surgery Patient Safety Organization
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 19 Dec 2019 (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.
Objectives
- The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. By linking VQI patients to Medicare claims retrospectively from 2012 to 2016, we will be able to identify additional paclitaxel devices enabling longitudinal follow-up of mortality out to 5 years for paclitaxel-eluting stents and 3 years for paclitaxel-coated balloons.
- To analyze factors associated with mortality, specifically comparing paclitaxel patients surviving vs. paclitaxel patients with mortality. The goal is to identify independent factors predictive of mortality in US pivotal trials and model registry data exposures with sufficient factors to track competing risk paradox and show emulation or not of mortality outcomes with both PTX and PTA exposures.
- To confirm the effectiveness of paclitaxel devices by comparing reintervention for paclitaxel and non-paclitaxel devices. In-hospital mortality from open and percutaneous target vessel revascularization (TVR) will be reported to determine the impact of subsequent revascularizations on survival. Major amputation will be comparted for patients with chronic limb-threatening ischemia.
Detailed description
The proposed safety analyses will evaluate two types of paclitaxel-coated interventional devices used to treat PAD and compare patient outcomes with propensity score-matched patients of similar risk who receive non-paclitaxel devices.
The primary outcome will be freedom from all-cause death using propensity-matched survival analysis.
Three principle analyses are planned:
- Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact Admiral, and Philips Spectranetics Stellarex DCB's) as compared with propensity-matched patients treated with plain balloons.
- Paclitaxel delivering DES (Cook Zilver PTX) as compared with propensity-matched cases using bare-metal stents (BMS).
- Patients treated with either Paclitaxel DCB or Paclitaxel DES compared with propensity-matched controls (with DCB patients matched to patients treated with plain balloons, and DES patients matched to patients treated with BMS).
Note that this analysis is planned at the device class level and is not intended to compare early or late mortality between specific devices or brands.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| paclitaxel coated balloon angioplasty | – | Device: pactlitaxel PAD deviceProcedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery |
| plain balloon angioplasty | – | –Procedures with plain balloon angioplasty of the superficial femoral-popliteal artery |
| paclitaxel eluting stent | – | Device: pactlitaxel PAD deviceProcedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery |
| bare metal stenting | – | –Procedures with bare metal self expanding stenting of the superficial femoral-popliteal artery |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients, aged 65 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 10/1/2012 and the latest available CMS dataset (12/31/2016) will be included.
Key inclusion criteria (4 listed)
- Age ≥ 65 years old
- Date of index procedure is within 10/1/2012 to 12/31/2016
- Symptomatic disease ranging from intermittent claudication to chronic limb-threatening ischemia (including ischemic rest pain and/or tissue loss)
- Elective or urgent procedures
Key exclusion criteria (5 listed)
- Aneurysmal disease of the superficial femoral or popliteal artery
- Treatment for acute limb ischemia
- Treatment of common femoral artery or profunda femoral artery occlusive disease
- Emergency procedures
- PVI and concomitant femoral endarterectomy, suprainguinal or infrainguinal bypass
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 |
|---|---|---|
| pactlitaxel PAD deviceAlso: Medtronic INPact Admiral, Bard Lutonix, Cook Zilver PTX stentPeripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices. | Device | paclitaxel coated balloon angioplasty, paclitaxel eluting stent |
Primary outcome
overall mortality
Time frame: 1 year
death from any cause
overall mortality
Time frame: 3 years
death from any cause
overall mortality
Time frame: 5 years
death from any cause
2 secondary outcomes
target vessel revascularization (TVR)
Time frame: 1-3-5 years
Major amputation
Time frame: 1-3-5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Background: PubMed 30561254Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.
- Background: PubMed 29914838Columbo JA, Kang R, Hoel AW, Kang J, Leinweber KA, Tauber KS, Hila R, Ramkumar N, Sedrakyan A, Goodney PP. A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review. J Vasc Surg. 2019 Jan;69(1):74-79.e6. doi: 10.1016/j.jvs.2018.03.423. Epub 2018 Jun 15.
- Background: PubMed 19317587Schillinger M, Minar E. Past, present and future of femoropopliteal stenting. J Endovasc Ther. 2009 Feb;16 Suppl 1:I147-52. doi: 10.1583/1545-1550-16.16.I-147.
- Background: PubMed 19859954Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, Koppensteiner R, Minar E, Schillinger M. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1090-5. doi: 10.1002/ccd.22128.
- Background: PubMed 24959692Chowdhury MM, McLain AD, Twine CP. Angioplasty versus bare metal stenting for superficial femoral artery lesions. Cochrane Database Syst Rev. 2014 Jun 24;2014(6):CD006767. doi: 10.1002/14651858.CD006767.pub3.
- Background: PubMed 14501504Eliason JL, Wainess RM, Proctor MC, Dimick JB, Cowan JA Jr, Upchurch GR Jr, Stanley JC, Henke PK. A national and single institutional experience in the contemporary treatment of acute lower extremity ischemia. Ann Surg. 2003 Sep;238(3):382-9; discussion 389-90. doi: 10.1097/01.sla.0000086663.49670.d1.
- Background: PubMed 15111854Earnshaw JJ, Whitman B, Foy C. National Audit of Thrombolysis for Acute Leg Ischemia (NATALI): clinical factors associated with early outcome. J Vasc Surg. 2004 May;39(5):1018-25. doi: 10.1016/j.jvs.2004.01.019.
- Background: PubMed 26350058Howard DP, Banerjee A, Fairhead JF, Hands L, Silver LE, Rothwell PM; Oxford Vascular Study. Population-Based Study of Incidence, Risk Factors, Outcome, and Prognosis of Ischemic Peripheral Arterial Events: Implications for Prevention. Circulation. 2015 Nov 10;132(19):1805-15. doi: 10.1161/CIRCULATIONAHA.115.016424. Epub 2015 Sep 8.
- Background: PubMed 24768362Baril DT, Ghosh K, Rosen AB. Trends in the incidence, treatment, and outcomes of acute lower extremity ischemia in the United States Medicare population. J Vasc Surg. 2014 Sep;60(3):669-77.e2. doi: 10.1016/j.jvs.2014.03.244. Epub 2014 Apr 24.
- Background: PubMed 27851991Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Mar 21;69(11):1465-1508. doi: 10.1016/j.jacc.2016.11.008. Epub 2016 Nov 13. No abstract available.
- Background: PubMed 20572124Oakes D, Feng C. Combining stratified and unstratified log-rank tests in paired survival data. Stat Med. 2010 Jul 20;29(16):1735-45. doi: 10.1002/sim.3921.
- BackgroundM Grambsch and TM Therneau, Proportional Hazards Tests and Diagnostics Based on Weighted Residuals, Biometrika 1994, 81(3): 515-526, https://doi.org/10.1093/biomet/81.3.515
- Individual participant dataSharing planned: No
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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.
Daniel Bertges, MD principal investigator
SVS VQI
Philip Goodney, MD study director
SVS VQI
Art Sedrakyan, PhD study director
Weill Medical College of Cornell University
Questions about this trial
What is this clinical trial studying?
An observational study of PAD, run by University of Vermont Medical Center.
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 4 inclusion and 5 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 19 Dec 2019. 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?
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?
overall mortality (time frame: 1 year). The study lists 3 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 NCT04204564, which also lists 15 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 19 Dec 2019.