Peripheral Vascular DiseaseNCT02734095
Determining Predictors of Restenosis in Femoropopliteal Lesions
A study testing Ultrasound in people with Peripheral Vascular Disease, run by University of Campinas, Brazil.
Trial summary
A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2018
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
- Successful lesion passage passed with conventional mechanical guidewires;
- Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
- Life-expectancy of more than 12 months;
- Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
- Te patient must provide written patient informed consent that is approved by the ethics committee.
Who cannot join
- Patient refusing treatment;
- The reference segment diameter is not suitable fo available balloon and/or stent design;
- Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis;
- Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
- The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
- The patent has a history of prior life-threatening contrast media reaction;
Show all 9Show fewer
- The patient is currently enrolled in another investigational device or drug trial;
- The patient is currently breast-feeding, pregnant or intends to become pregnant;
- The patient is mentally ill or retarded.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions
A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
Read the detailed description
Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.
However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.
The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Ultrasound
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Intravascular Ultrasound data | Experimental | Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Burden Measure
defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area
Measured: intraoperative
Reference Lumen Measure
defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5
Measured: intraoperative
Reference Diameter Measure
defined as = (proximal reference diameter + distal reference diameter) x 0.5
Measured: intraoperative
Stent/reference Diameter Ratio Measure
defined as = stent diameter ÷ reference diameter
Measured: intraoperative
Stent Expansion Ratio Measure
defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area
Measured: intraoperative
Radial Stent Symmetry Index Measure
defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area
Measured: intraoperative
Axial Stent Symmetry Index Measure
defined as = minimum ÷ maximum stent cross-sectional area
Measured: intraoperative
In Stent Restenosis
Measured: 12 months (±30 days)
Secondary outcomes (21)
Technical success
defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater tha 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging.
Measured: intraoperative
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Measured: Baseline
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Measured: 1 month (± 7 days)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Measured: 3 months (±30 days)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Measured: 6 months (±30 days)
Freedom of reintervention at each follow-up
defined as freedom from target lesion revascularization (TLR)
Measured: 12 months (±30 days)
Limb-salvage rate
defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Measured: Baseline
Limb-salvage rate
defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Measured: 1 month (± 7 days)
Limb-salvage rate
defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Measured: 3 months (±30 days)
Limb-salvage rate
defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Measured: 6 months (±30 days)
Limb-salvage rate
defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot)
Measured: 12 months (±30 days)
Serious adverse events
defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: Baseline
Serious adverse events
defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: 1 month (± 7 days)
Serious adverse events
defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: 3 months (±30 days)
Serious adverse events
defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: 6 months (±30 days)
Serious adverse events
defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Measured: 12 months (±30 days)
Clinical success at follow-up
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Measured: Baseline
Clinical success at follow-up
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 1 month (± 7 days)
Clinical success at follow-up
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 3 months (±30 days)
Clinical success at follow-up
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 6 months (±30 days)
Clinical success at follow-up
defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 12 months (±30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Martin Andreas Geiger, University of Campinas, Brazil
- Investigators
- Martin A Geiger, MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734095
- Sponsor's protocol ID
- 52994416.7.0000.5404
- Status last verified
- Apr 2016
- First submitted
- 23 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
DOTTER CT, JUDKINS MP. TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION. Circulation. 1964 Nov;30:654-70. doi: 10.1161/01.cir.30.5.654. No abstract available.
PubMed 14226164Dettinger GB. Defending the military family. Am J Psychiatry. 1979 Jun;136(6):855-6. doi: 10.1176/ajp.136.6.855. No abstract available.
PubMed 443484Pentecost MJ, Criqui MH, Dorros G, Goldstone J, Johnston KW, Martin EC, Ring EJ, Spies JB. Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels. A statement for health professionals from a special writing group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association. Circulation. 1994 Jan;89(1):511-31. doi: 10.1161/01.cir.89.1.511. No abstract available.
PubMed 8281692Martin EC, Katzen BT, Benenati JF, Diethrich EB, Dorros G, Graor RA, Horton KM, Iannone LA, Isner JM, Ramee SR, et al. Multicenter trial of the wallstent in the iliac and femoral arteries. J Vasc Interv Radiol. 1995 Nov-Dec;6(6):843-9. doi: 10.1016/s1051-0443(95)71198-8.
PubMed 8850658Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595.
PubMed 11012429Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.
PubMed 9068071Ferreira M, Lanziotti L, Monteiro M, Abuhadba G, Capotorto LF, Nolte L, Fearnot N. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):702-8. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24.
PubMed 17920306Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1.
PubMed 19642788Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.
PubMed 24754279
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions
- ClinicalTrials.gov ID
- NCT02734095
- Acronym / sponsor ID
- 52994416.7.0000.5404
- Conditions
- Peripheral Vascular Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Aug 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 12 Apr 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.
A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
Detailed description
Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.
However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.
The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravascular Ultrasound data | Experimental | Device: UltrasoundIntravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
- Successful lesion passage passed with conventional mechanical guidewires;
- Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
- Life-expectancy of more than 12 months;
- Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
Key exclusion criteria (9 listed)
- Patient refusing treatment;
- The reference segment diameter is not suitable fo available balloon and/or stent design;
- Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis;
- Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
- The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
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 |
|---|---|---|
| UltrasoundIntravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions. | Device | Intravascular Ultrasound data |
Primary outcome
Plaque Burden Measure
Time frame: intraoperative
defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area
Reference Lumen Measure
Time frame: intraoperative
defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5
Reference Diameter Measure
Time frame: intraoperative
defined as = (proximal reference diameter + distal reference diameter) x 0.5
Stent/reference Diameter Ratio Measure
Time frame: intraoperative
defined as = stent diameter ÷ reference diameter
Stent Expansion Ratio Measure
Time frame: intraoperative
defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area
Radial Stent Symmetry Index Measure
Time frame: intraoperative
defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area
Axial Stent Symmetry Index Measure
Time frame: intraoperative
defined as = minimum ÷ maximum stent cross-sectional area
In Stent Restenosis
Time frame: 12 months (±30 days)
21 secondary outcomes
Technical success
Time frame: intraoperative
Freedom of reintervention at each follow-up
Time frame: Baseline
Freedom of reintervention at each follow-up
Time frame: 1 month (± 7 days)
Freedom of reintervention at each follow-up
Time frame: 3 months (±30 days)
Freedom of reintervention at each follow-up
Time frame: 6 months (±30 days)
Freedom of reintervention at each follow-up
Time frame: 12 months (±30 days)
Limb-salvage rate
Time frame: Baseline
Limb-salvage rate
Time frame: 1 month (± 7 days)
Limb-salvage rate
Time frame: 3 months (±30 days)
Limb-salvage rate
Time frame: 6 months (±30 days)
Limb-salvage rate
Time frame: 12 months (±30 days)
Serious adverse events
Time frame: Baseline
Serious adverse events
Time frame: 1 month (± 7 days)
Serious adverse events
Time frame: 3 months (±30 days)
Serious adverse events
Time frame: 6 months (±30 days)
Serious adverse events
Time frame: 12 months (±30 days)
Clinical success at follow-up
Time frame: Baseline
Clinical success at follow-up
Time frame: 1 month (± 7 days)
Clinical success at follow-up
Time frame: 3 months (±30 days)
Clinical success at follow-up
Time frame: 6 months (±30 days)
Clinical success at follow-up
Time frame: 12 months (±30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Background: PubMed 14226164DOTTER CT, JUDKINS MP. TRANSLUMINAL TREATMENT OF ARTERIOSCLEROTIC OBSTRUCTION. DESCRIPTION OF A NEW TECHNIC AND A PRELIMINARY REPORT OF ITS APPLICATION. Circulation. 1964 Nov;30:654-70. doi: 10.1161/01.cir.30.5.654. No abstract available.
- Background: PubMed 443484Dettinger GB. Defending the military family. Am J Psychiatry. 1979 Jun;136(6):855-6. doi: 10.1176/ajp.136.6.855. No abstract available.
- Background: PubMed 8281692Pentecost MJ, Criqui MH, Dorros G, Goldstone J, Johnston KW, Martin EC, Ring EJ, Spies JB. Guidelines for peripheral percutaneous transluminal angioplasty of the abdominal aorta and lower extremity vessels. A statement for health professionals from a special writing group of the Councils on Cardiovascular Radiology, Arteriosclerosis, Cardio-Thoracic and Vascular Surgery, Clinical Cardiology, and Epidemiology and Prevention, the American Heart Association. Circulation. 1994 Jan;89(1):511-31. doi: 10.1161/01.cir.89.1.511. No abstract available.
- Background: PubMed 8850658Martin EC, Katzen BT, Benenati JF, Diethrich EB, Dorros G, Graor RA, Horton KM, Iannone LA, Isner JM, Ramee SR, et al. Multicenter trial of the wallstent in the iliac and femoral arteries. J Vasc Interv Radiol. 1995 Nov-Dec;6(6):843-9. doi: 10.1016/s1051-0443(95)71198-8.
- Background: PubMed 11012429Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595.
- Background: PubMed 9068071Gray BH, Olin JW. Limitations of percutaneous transluminal angioplasty with stenting for femoropopliteal arterial occlusive disease. Semin Vasc Surg. 1997 Mar;10(1):8-16.
- Background: PubMed 17920306Ferreira M, Lanziotti L, Monteiro M, Abuhadba G, Capotorto LF, Nolte L, Fearnot N. Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results. Eur J Vasc Endovasc Surg. 2007 Dec;34(6):702-8. doi: 10.1016/j.ejvs.2007.07.025. Epub 2007 Oct 24.
- Background: PubMed 19642788Bosiers M, Torsello G, Gissler HM, Ruef J, Muller-Hulsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroe H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009 Jun;16(3):261-9. doi: 10.1583/08-2676.1.
- Background: PubMed 24754279Laird JR, Jain A, Zeller T, Feldman R, Scheinert D, Popma JJ, Armstrong EJ, Jaff MR; Complete SE Investigators. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014 Apr;21(2):202-12. doi: 10.1583/13-4548R.1.
- Individual participant dataSharing planned: Undecided
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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 A Geiger, MD principal investigator
University of Campinas, Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Peripheral Vascular Disease, run by University of Campinas, Brazil.
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 6 inclusion and 9 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 12 Apr 2016. 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 Martin A Geiger, MD (+55 19 35218936, martinandreasgeiger@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Burden Measure (time frame: intraoperative). The study lists 8 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 NCT02734095, which also lists 9 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 12 Apr 2016.