RestenosisPacTAPNCT01599078
Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention
A study testing Paclitaxel in people with Restenosis and Peripheral Arterial Disease, run by Midwest Cardiovascular Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restenosis, Peripheral Arterial Disease
- What is being tested?
- Paclitaxel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jan 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Subject able to provide informed consent and agree to all follow up requirements.
- Peripheral arterial disease with Rutherford Class 2-5.
- Successful percutaneous revascularization of the femoropopliteal artery (< 20% residual stenosis by visual estimate) using standard techniques per discretion of the local operator.
- The femoropopliteal Reference Vessel Diameter (RVD) must be ≥4.0 mm and ≤7.0 mm
Who cannot join
- Patient is pregnant or breast feeding. (Female subjects of childbearing potential must have negative serum pregnancy test the day of the procedure.)
- Life expectancy < 12 months.
- Contraindication to aspirin, anti-platelet/anti-coagulant therapies required for procedure/follow up.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Known allergy to paclitaxel.
- Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
Show all 14Show fewer
- Simultaneous enrollment in another investigational device or drug study.
- Previous intervention of the target limb with a drug eluting stent or drug eluting balloon.
- Absence of at least 1 TIMI-3 vessel run off into the foot.
- Total bilirubin > 2x upper limit of normal (ULN).
- ALT or AST > 3x ULN.
- Platelet count < 100,000/mm3.
- White blood cell count < 1.5/mm3.
- Any evidence of perforation or dye extravasation during the index procedure, even if successfully treated with a covered stent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Trinity Medical Center
Bettendorf, Iowa, 52722
Eric J Dippel, MD, 563-324-2828, dippel@cvmedpc.com
Eric J Dippel, MD
About this study
Official title: Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention (PacTAP Study): A Double Blind, Randomized Control Study
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
Read the detailed description
Peripheral artery disease (PAD) of the lower extremities is an extremely prevalent disorder and is an important cause of morbidity that affects more than 10 million people in the United States. This disorder is typically caused by atherosclerosis that limits blood flow to the limbs, particularly due to stenosis or occlusion of the superficial femoral artery (SFA) and/or popliteal artery. Although many patients are asymptomatic or are treated with lifestyle changes, such as exercise therapy, or pharmacological treatment, including statins and anti-platelet therapy, about 10-15% of patients have progressive symptoms which in severe cases may lead to amputation.
Endovascular treatment with percutaneous vascular intervention (PVI), which includes percutaneous transluminal angioplasty (PTA), stenting, atherectomy and thrombolytic therapy, can provide excellent acute success rates greater than 90-95% However, the intermediate to long-term patency rates of these arteries is hampered by neointimal hyperplasia resulting in restenosis of the artery. This occurs with all endovascular therapy to some degree in both the coronary and peripheral arena. With PVI in the superficial femoral and popliteal arteries the restenosis rates are approximately 30-40% at 12 months, depending on the complexity and severity of the disease.
In the coronary field, stents are now coated with anti-restenotic pharmacologic agents (drug eluting stents-DES) such as paclitaxel and sirolimus-like drugs that prevent neointimal growth. There have been published reports of significant efficacy in preventing restenosis in the SFA by coating balloons with paclitaxel (drug eluting balloons-DEB) as well as a nitinol stent. Despite the fact that these products are CE Mark approved and available in Europe, currently there are no US FDA approved drug-eluting devices for use in PVI. Thus, there remains a need for an alternative therapy to prevent restenosis in the SFA following endovascular intervention.
Administration of intra-arterial paclitaxel mixed with iodinated contrast has been shown to inhibit restenosis in a porcine coronary model.
Delivering paclitaxel intra-arterially in the coronary tree following stent implantation has shown benefit in reducing the incidence of restenosis. The novel Targeted Adjustable Pharmaceutical Application System (TAPAS)-TAPAS Catheter Therapeutic Infusion System (ThermopeutiX, San Diego, CA, USA)-is a drug delivery catheter that consists of a proximal and distal occlusion balloon with an adjustable length that allows a drug to dwell in a specific segment of the artery for a period of time. The drug can then be aspirated and discarded to avoid systemic exposure.
The PacTAP study is a randomized, double blind, placebo-control study to assess the safety and efficacy of delivering intra-arterial paclitaxel via the TAPAS catheter following PVI to prevent restenosis.
- Conditions
- Restenosis, Peripheral Arterial Disease
- Being tested
- Paclitaxel, Placebo
- Keywords
- Restenosis, Angioplasty, Stent, Atherectomy, Femoral Artery, Popliteal Artery, Paclitaxel
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Drug dosing is 3mcg/mm3 of artery treated with percutaneous revascularization. Drug will be administered via the TAPAS catheter and allowed to dwell for 5 minutes.
PlaceboDrug
Saline will be administered intra-arterially via the TAPAS catheter following percutaneous revascularization. The dwell time will be 5minutes.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Paclitaxel | Active comparator | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency
Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) or a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS)
Measured: 6 months
Primary Safety
Freedom from death, major amputation in the target limb, or Target Lesion Revascularization (either surgical or endovascular)
Measured: 30 days
Secondary outcomes (5)
Primary Patency at 12 months
Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) or a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS)
Measured: 12 months
Primary Assisted Patency
Patency of the target vessel regardless of secondary interventions performed to restore blood flow after restenosis.
Measured: 6 and 12 months
Secondary Patency
Patency of the target vessel regardless of secondary interventions performed to restore blood flow after reocclusion.
Measured: 6 and 12 months
Functional Status
Walking Impairment Questionnaire (WIQ), and Rutherford Classification.
Measured: 30 days, 6 months, and 12 months
Secondary Safety
Any adverse events associated with the use of paclitaxel, such as, but not limited to: hypotension, anaphylactic reactions, nausea, vomiting, diarrhea, pancytopenia, neuropathy, alopecia.
Measured: 30 days, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
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 RestenosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwest Cardiovascular Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Spectranetics Corporation
- Responsible party
- Principal investigator, Eric J Dippel, MD, Midwest Cardiovascular Research Foundation
- Investigators
- Eric J Dippel, MD, Principal investigator, Midwest Cardiovascular Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599078
- Sponsor's protocol ID
- MCRF-001-EJD
- Acronym
- PacTAP
- Status last verified
- May 2012
- First submitted
- 13 May 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
PubMed 18272892Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
PubMed 18779447Hawkins BM, Hennebry TA. Local paclitaxel delivery for treatment of peripheral arterial disease. Circ Cardiovasc Interv. 2011 Jun;4(3):297-302. doi: 10.1161/CIRCINTERVENTIONS.110.961052. Epub 2011 May 3. No abstract available.
PubMed 21540442Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
PubMed 21953370Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.
PubMed 15076010Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.
PubMed 14563585Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.
PubMed 20031731Margolis J, McDonald J, Heuser R, Klinke P, Waksman R, Virmani R, Desai N, Hilton D. Systemic nanoparticle paclitaxel (nab-paclitaxel) for in-stent restenosis I (SNAPIST-I): a first-in-human safety and dose-finding study. Clin Cardiol. 2007 Apr;30(4):165-70. doi: 10.1002/clc.20066.
PubMed 17443649
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention (PacTAP Study): A Double Blind, Randomized Control Study
- ClinicalTrials.gov ID
- NCT01599078
- Acronym / sponsor ID
- PacTAP / MCRF-001-EJD
- Conditions
- Restenosis, Peripheral Arterial Disease
- Keywords
- Restenosis, Angioplasty, Stent, Atherectomy, Femoral Artery, Popliteal Artery, Paclitaxel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Midwest Cardiovascular Research FoundationUniversity, hospital or other
- Collaborators
- Spectranetics Corporation
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 15 May 2012 (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.
The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.
Detailed description
Peripheral artery disease (PAD) of the lower extremities is an extremely prevalent disorder and is an important cause of morbidity that affects more than 10 million people in the United States. This disorder is typically caused by atherosclerosis that limits blood flow to the limbs, particularly due to stenosis or occlusion of the superficial femoral artery (SFA) and/or popliteal artery. Although many patients are asymptomatic or are treated with lifestyle changes, such as exercise therapy, or pharmacological treatment, including statins and anti-platelet therapy, about 10-15% of patients have progressive symptoms which in severe cases may lead to amputation.
Endovascular treatment with percutaneous vascular intervention (PVI), which includes percutaneous transluminal angioplasty (PTA), stenting, atherectomy and thrombolytic therapy, can provide excellent acute success rates greater than 90-95% However, the intermediate to long-term patency rates of these arteries is hampered by neointimal hyperplasia resulting in restenosis of the artery. This occurs with all endovascular therapy to some degree in both the coronary and peripheral arena. With PVI in the superficial femoral and popliteal arteries the restenosis rates are approximately 30-40% at 12 months, depending on the complexity and severity of the disease.
In the coronary field, stents are now coated with anti-restenotic pharmacologic agents (drug eluting stents-DES) such as paclitaxel and sirolimus-like drugs that prevent neointimal growth. There have been published reports of significant efficacy in preventing restenosis in the SFA by coating balloons with paclitaxel (drug eluting balloons-DEB) as well as a nitinol stent. Despite the fact that these products are CE Mark approved and available in Europe, currently there are no US FDA approved drug-eluting devices for use in PVI. Thus, there remains a need for an alternative therapy to prevent restenosis in the SFA following endovascular intervention.
Administration of intra-arterial paclitaxel mixed with iodinated contrast has been shown to inhibit restenosis in a porcine coronary model.
Delivering paclitaxel intra-arterially in the coronary tree following stent implantation has shown benefit in reducing the incidence of restenosis. The novel Targeted Adjustable Pharmaceutical Application System (TAPAS)-TAPAS Catheter Therapeutic Infusion System (ThermopeutiX, San Diego, CA, USA)-is a drug delivery catheter that consists of a proximal and distal occlusion balloon with an adjustable length that allows a drug to dwell in a specific segment of the artery for a period of time. The drug can then be aspirated and discarded to avoid systemic exposure.
The PacTAP study is a randomized, double blind, placebo-control study to assess the safety and efficacy of delivering intra-arterial paclitaxel via the TAPAS catheter following PVI to prevent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Paclitaxel | Active comparator | Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old.
- Subject able to provide informed consent and agree to all follow up requirements.
- Peripheral arterial disease with Rutherford Class 2-5.
- Successful percutaneous revascularization of the femoropopliteal artery (< 20% residual stenosis by visual estimate) using standard techniques per discretion of the local operator.
- The femoropopliteal Reference Vessel Diameter (RVD) must be ≥4.0 mm and ≤7.0 mm
Key exclusion criteria (14 listed)
- Patient is pregnant or breast feeding. (Female subjects of childbearing potential must have negative serum pregnancy test the day of the procedure.)
- Life expectancy < 12 months.
- Contraindication to aspirin, anti-platelet/anti-coagulant therapies required for procedure/follow up.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Known allergy to paclitaxel.
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 |
|---|---|---|
| PaclitaxelAlso: TaxolDrug dosing is 3mcg/mm3 of artery treated with percutaneous revascularization. Drug will be administered via the TAPAS catheter and allowed to dwell for 5 minutes. | Drug | Paclitaxel |
| PlaceboSaline will be administered intra-arterially via the TAPAS catheter following percutaneous revascularization. The dwell time will be 5minutes. | Drug | Placebo |
Primary outcome
Primary Patency
Time frame: 6 months
Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) or a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS)
Primary Safety
Time frame: 30 days
Freedom from death, major amputation in the target limb, or Target Lesion Revascularization (either surgical or endovascular)
5 secondary outcomes
Primary Patency at 12 months
Time frame: 12 months
Primary Assisted Patency
Time frame: 6 and 12 months
Secondary Patency
Time frame: 6 and 12 months
Functional Status
Time frame: 30 days, 6 months, and 12 months
Secondary Safety
Time frame: 30 days, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Background: PubMed 18272892Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
- Background: PubMed 18779447Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.
- Background: PubMed 21540442Hawkins BM, Hennebry TA. Local paclitaxel delivery for treatment of peripheral arterial disease. Circ Cardiovasc Interv. 2011 Jun;4(3):297-302. doi: 10.1161/CIRCINTERVENTIONS.110.961052. Epub 2011 May 3. No abstract available.
- Background: PubMed 21953370Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.
- Background: PubMed 15076010Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.
- Background: PubMed 14563585Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.
- Background: PubMed 20031731Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.
- Background: PubMed 17443649Margolis J, McDonald J, Heuser R, Klinke P, Waksman R, Virmani R, Desai N, Hilton D. Systemic nanoparticle paclitaxel (nab-paclitaxel) for in-stent restenosis I (SNAPIST-I): a first-in-human safety and dose-finding study. Clin Cardiol. 2007 Apr;30(4):165-70. doi: 10.1002/clc.20066.
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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.
Eric J Dippel, MD principal investigator
Midwest Cardiovascular Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel in people with Restenosis and Peripheral Arterial Disease, run by Midwest Cardiovascular Research Foundation at 1 site in United States.
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 5 inclusion and 14 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 15 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 Eric J Dippel, MD (563-324-2828, dippel@cvmedpc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency (time frame: 6 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 NCT01599078, 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 15 May 2012.