Coronary DiseaseCHANCENCT03622203
Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent
An observational study of Coronary Disease and Drug Eluting Stent, run by A.O.U. Città della Salute e della Scienza.
Trial summary
Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist. Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival [1]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Drug Eluting Stent, STEMI
- What is being tested?
- Biofreedom
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients implanting Biofreedom with these prespecified analysis: 1. Clinical * Diabetic patients (both insulin and not insulin depenent) * Requiring oral anticoagulation * On active cancer (that is requiring chemio or radio-therapy and or surgery) * Requiring surgery * STEMI 2. Interventional * Bifurcation (both provisional both 2 stents) * Multivessel * Ostial
Who may be able to join
- Clinical
- Diabetic patients (both insulin and not insulin depenent)
- Requiring oral anticoagulation
- On active cancer (that is requiring chemio or radio-therapy and or surgery)
- Requiring surgery
- STEMI
Show all 10Show fewer
- Interventional
- Bifurcation (both provisional both 2 stents)
- Multivessel
- Ostial
Who cannot join
- clinical less than 18 years old or more than 80
- interventional last remaing vessel
About this study
Official title: Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent ("Biofreedom"): the CHANCE a Multicenter Study
Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist.
Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival [1].
Read more
Recently a Polymer-free Drug-Coated coronary stent has been tested in a randomized controlled trial with only one month of DAT due to its peculiar features, with an increased efficacy compared to BMS (Bare Metal Stent) and with a not negligible risk of ST at one year (about 2%)[2,3].
The RCT despite its promising design (inclusion of high risk patients like those with previous bleeding or with severe renal disease) showed a major limitation, that is:
- patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation)
- and patients with bifurcation and multivessel disease, that is those with an increased risk of ST [4]
- STEMI patients [5] were underrepresented (less than 30%). Consequently we performed this multicenter study to evaluate safety and efficacy of Biofreedom in real life patients.
POCE (a composite end point of death, myocardial infarction, target lesion revascularization) and DOCE (cardiac death, MI-TLR and TLR) will be the primary end points, while its single components will be the secondary ones along stent thrombosis and with bleedings (Barc classification).
At least 12 months The Leaders FREE (2) reported an incidence of MACE of 9.4% at one year in overall patients. If there is a true difference in favour of the experimental treatment of 1.2%, then 870 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference when compared to non selected patients of more than 2% [5]
All patients implanting Biofreedom with these prespecified analysis:
- Clinical
- Diabetic patients (both insulin and not insulin depenent)
- Requiring oral anticoagulation
- On active cancer (that is requiring chemio or radio-therapy and or surgery)
- Requiring surgery
- STEMI
- Interventional
- Bifurcation (both provisional both 2 stents)
- Multivessel
- Ostial
Read the detailed description
Our interest is to test the performance of these stents in real life patients
- Conditions
- Coronary Disease, Drug Eluting Stent, STEMI
- Being tested
- Biofreedom
- Medical subject headings
- Coronary Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofreedomDevice
Use of Biofreedom in real life patients
| Study group | Role | What they receive |
|---|---|---|
| Real life patients | Patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation) Receives: Device: Biofreedom | |
| Difficult coronary lesions | Patients with bifurcation and multivessel disease, that is those with an increased risk of ST Receives: Device: Biofreedom | |
| STEMI | Patients with STEMI Receives: Device: Biofreedom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POCE (primary patient-oriented endpoint)
Incidence of POCE (a composite and mutual exclusive end point of death, myocardial infarction, target lesion revascularization)
Measured: At least 6 months
Secondary outcomes (5)
Incidence of Death
Incidence of Death
Measured: At least 6 months
Incidence of Myocardial Infarction
Incidence of Myocardial Infarction
Measured: At least 6 months
Incidence of TLR
Incidence of target lesion revascularization
Measured: At least 6 months
Incidence of Cardiac Death
Incidence of Cardiac Death
Measured: At least 6 months
Incidence of MI-TLR
Incidence of Myocardia Infarction TLR
Measured: At least 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jan 2016
- Primary completion31 Jan 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
- Investigators
- Fabrizio D'Ascenzo, Principal investigator, Città della Salute e Della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622203
- Sponsor's protocol ID
- CHANCE
- Acronym
- CHANCE
- Status last verified
- Aug 2018
- First submitted
- 18 May 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.
PubMed 25399658Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
PubMed 26466021Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrie D, Naber C, Iniguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhovel U, Greene S, Stoll HP, Urban P; LEADERS FREE Investigators. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. J Am Coll Cardiol. 2017 Jan 17;69(2):162-171. doi: 10.1016/j.jacc.2016.10.009. Epub 2016 Oct 30.
PubMed 27806919D'Ascenzo F, Bollati M, Clementi F, Castagno D, Lagerqvist B, de la Torre Hernandez JM, ten Berg JM, Brodie BR, Urban P, Jensen LO, Sardi G, Waksman R, Lasala JM, Schulz S, Stone GW, Airoldi F, Colombo A, Lemesle G, Applegate RJ, Buonamici P, Kirtane AJ, Undas A, Sheiban I, Gaita F, Sangiorgi G, Modena MG, Frati G, Biondi-Zoccai G. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013 Jul 31;167(2):575-84. doi: 10.1016/j.ijcard.2012.01.080. Epub 2012 Feb 22.
PubMed 22360945Naber CK, Urban P, Ong PJ, Valdes-Chavarri M, Abizaid AA, Pocock SJ, Fabbiocchi F, Dubois C, Copt S, Greene S, Morice MC; LEADERS FREE Investigators. Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study. Eur Heart J. 2017 Apr 1;38(13):961-969. doi: 10.1093/eurheartj/ehw203.
PubMed 27190095Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.
PubMed 7160191Gallone G, D'Ascenzo F, Boccuzzi G, Cortese B, Di Biasi M, Omede P, Capodanno D, Cerrato E, Vicinelli P, Infantino V, Poli A, Ugo F, Conrotto F, Grigis G, Varbella F, Latini RA, D'Urbano M, Montabone A, Senatore G, Ferrara E, D'Amico M, De Ferrari GM, Ielasi A. Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent. Catheter Cardiovasc Interv. 2020 Sep 1;96(3):E248-E256. doi: 10.1002/ccd.28757. Epub 2020 Feb 3.
PubMed 32012453D'Ascenzo F, Gallone G, Boccuzzi G, Cortese B, Di Biasi M, Capodanno D, Vicinelli P, Infantino V, Poli A, Grigis G, Varbella F, De Ferrari GM, Ielasi A; Collaborators. Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents. EuroIntervention. 2020 Feb 7;15(15):e1358-e1365. doi: 10.4244/EIJ-D-19-00450.
PubMed 31334704
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent ("Biofreedom"): the CHANCE a Multicenter Study
- ClinicalTrials.gov ID
- NCT03622203
- Acronym / sponsor ID
- CHANCE / CHANCE
- Conditions
- Coronary Disease, Drug Eluting Stent, STEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 9 Aug 2018 (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.
Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist.
Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival [1].
Recently a Polymer-free Drug-Coated coronary stent has been tested in a randomized controlled trial with only one month of DAT due to its peculiar features, with an increased efficacy compared to BMS (Bare Metal Stent) and with a not negligible risk of ST at one year (about 2%)[2,3].
The RCT despite its promising design (inclusion of high risk patients like those with previous bleeding or with severe renal disease) showed a major limitation, that is:
- patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation)
- and patients with bifurcation and multivessel disease, that is those with an increased risk of ST [4]
- STEMI patients [5] were underrepresented (less than 30%). Consequently we performed this multicenter study to evaluate safety and efficacy of Biofreedom in real life patients.
POCE (a composite end point of death, myocardial infarction, target lesion revascularization) and DOCE (cardiac death, MI-TLR and TLR) will be the primary end points, while its single components will be the secondary ones along stent thrombosis and with bleedings (Barc classification).
At least 12 months The Leaders FREE (2) reported an incidence of MACE of 9.4% at one year in overall patients. If there is a true difference in favour of the experimental treatment of 1.2%, then 870 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference when compared to non selected patients of more than 2% [5]
All patients implanting Biofreedom with these prespecified analysis:
- Clinical
- Diabetic patients (both insulin and not insulin depenent)
- Requiring oral anticoagulation
- On active cancer (that is requiring chemio or radio-therapy and or surgery)
- Requiring surgery
- STEMI
- Interventional
- Bifurcation (both provisional both 2 stents)
- Multivessel
- Ostial
Detailed description
Our interest is to test the performance of these stents in real life patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real life patients | – | Device: BiofreedomPatients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation) |
| Difficult coronary lesions | – | Device: BiofreedomPatients with bifurcation and multivessel disease, that is those with an increased risk of ST |
| STEMI | – | Device: BiofreedomPatients with STEMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients implanting Biofreedom with these prespecified analysis: 1. Clinical * Diabetic patients (both insulin and not insulin depenent) * Requiring oral anticoagulation * On active cancer (that is requiring chemio or radio-therapy and or surgery) * Requiring surgery * STEMI 2. Interventional * Bifurcation (both provisional both 2 stents) * Multivessel * Ostial
Key inclusion criteria (10 listed)
- Clinical
- Interventional
Key exclusion criteria (2 listed)
- clinical less than 18 years old or more than 80
- interventional last remaing vessel
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 |
|---|---|---|
| BiofreedomUse of Biofreedom in real life patients | Device | Difficult coronary lesions, Real life patients, STEMI |
Primary outcome
Incidence of POCE (primary patient-oriented endpoint)
Time frame: At least 6 months
Incidence of POCE (a composite and mutual exclusive end point of death, myocardial infarction, target lesion revascularization)
5 secondary outcomes
Incidence of Death
Time frame: At least 6 months
Incidence of Myocardial Infarction
Time frame: At least 6 months
Incidence of TLR
Time frame: At least 6 months
Incidence of Cardiac Death
Time frame: At least 6 months
Incidence of MI-TLR
Time frame: At least 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 25399658Mauri L, Kereiakes DJ, Yeh RW, Driscoll-Shempp P, Cutlip DE, Steg PG, Normand SL, Braunwald E, Wiviott SD, Cohen DJ, Holmes DR Jr, Krucoff MW, Hermiller J, Dauerman HL, Simon DI, Kandzari DE, Garratt KN, Lee DP, Pow TK, Ver Lee P, Rinaldi MJ, Massaro JM; DAPT Study Investigators. Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med. 2014 Dec 4;371(23):2155-66. doi: 10.1056/NEJMoa1409312. Epub 2014 Nov 16.
- Background: PubMed 26466021Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.
- Background: PubMed 27806919Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrie D, Naber C, Iniguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhovel U, Greene S, Stoll HP, Urban P; LEADERS FREE Investigators. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. J Am Coll Cardiol. 2017 Jan 17;69(2):162-171. doi: 10.1016/j.jacc.2016.10.009. Epub 2016 Oct 30.
- Background: PubMed 22360945D'Ascenzo F, Bollati M, Clementi F, Castagno D, Lagerqvist B, de la Torre Hernandez JM, ten Berg JM, Brodie BR, Urban P, Jensen LO, Sardi G, Waksman R, Lasala JM, Schulz S, Stone GW, Airoldi F, Colombo A, Lemesle G, Applegate RJ, Buonamici P, Kirtane AJ, Undas A, Sheiban I, Gaita F, Sangiorgi G, Modena MG, Frati G, Biondi-Zoccai G. Incidence and predictors of coronary stent thrombosis: evidence from an international collaborative meta-analysis including 30 studies, 221,066 patients, and 4276 thromboses. Int J Cardiol. 2013 Jul 31;167(2):575-84. doi: 10.1016/j.ijcard.2012.01.080. Epub 2012 Feb 22.
- Background: PubMed 27190095Naber CK, Urban P, Ong PJ, Valdes-Chavarri M, Abizaid AA, Pocock SJ, Fabbiocchi F, Dubois C, Copt S, Greene S, Morice MC; LEADERS FREE Investigators. Biolimus-A9 polymer-free coated stent in high bleeding risk patients with acute coronary syndrome: a Leaders Free ACS sub-study. Eur Heart J. 2017 Apr 1;38(13):961-969. doi: 10.1093/eurheartj/ehw203.
- Background: PubMed 7160191Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.
- Derived from this study: PubMed 32012453Gallone G, D'Ascenzo F, Boccuzzi G, Cortese B, Di Biasi M, Omede P, Capodanno D, Cerrato E, Vicinelli P, Infantino V, Poli A, Ugo F, Conrotto F, Grigis G, Varbella F, Latini RA, D'Urbano M, Montabone A, Senatore G, Ferrara E, D'Amico M, De Ferrari GM, Ielasi A. Real-world reasons and outcomes for 1-month versus longer dual antiplatelet therapy strategies with a polymer-free BIOLIMUS A9-coated stent. Catheter Cardiovasc Interv. 2020 Sep 1;96(3):E248-E256. doi: 10.1002/ccd.28757. Epub 2020 Feb 3.
- Derived from this study: PubMed 31334704D'Ascenzo F, Gallone G, Boccuzzi G, Cortese B, Di Biasi M, Capodanno D, Vicinelli P, Infantino V, Poli A, Grigis G, Varbella F, De Ferrari GM, Ielasi A; Collaborators. Dual antiplatelet therapy strategies and clinical outcomes in patients treated with polymer-free biolimus A9-coated stents. EuroIntervention. 2020 Feb 7;15(15):e1358-e1365. doi: 10.4244/EIJ-D-19-00450.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Fabrizio D'Ascenzo principal investigator
Città della Salute e Della Scienza di Torino
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Drug Eluting Stent, run by A.O.U. Città della Salute e della Scienza.
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 10 inclusion and 2 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: finished, as of the sponsor's last update on 9 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of POCE (primary patient-oriented endpoint) (time frame: At least 6 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 NCT03622203, which also lists 8 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 9 Aug 2018.