Thoracoabdominal Aortic AneurysmsNCT03075748
Visceral Manifold Study for the Repair of TAAA
A study testing TAAA Debranching Stent Graft System in people with Thoracoabdominal Aortic Aneurysms, run by University of South Florida at 2 sites in United States.
Trial summary
The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysms
- What is being tested?
- TAAA Debranching Stent Graft System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2017to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient may be entered into the study if the patient has at least one of the following:
- An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- Aneurysm with a history of growth > 0.5 cm in 6 months
- Saccular aneurysm deemed at significant risk for rupture
- Symptomatic aneurysm greater than 4.5 cm
- Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
Show all 26Show fewer
- Proximal landing zone for the thoracic bifurcation stent graft that has:
- ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
- Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
- Minimum branch vessel diameter greater than 5 mm
- Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
- Age: ≥ 18 years old
- Life expectancy: > 1 year
- Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:
- Minimum branch vessel diameter less than 5 mm
- Urgent or emergent presentation
- Patient has a contained rupture
- Patient has a ruptured aneurysm
- Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated
- Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
- Baseline creatinine greater than 2.0 mg/dL
- Anatomy that would not allow for maintenance of at least one hypogastric artery
- Anatomy that would not allow for primary or assisted patency of the left subclavian artery Or
- Patient that meets the criteria for inclusion in the primary study arm and:
- Would not be eligible for the primary study arm per a documented reason other than those outlined above, and
- Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
Who cannot join
- General exclusion
- Patient is a good candidate for and elects for open surgical repair
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent
Show all 28Show fewer
- Urgent or emergent presentation
- Patient is pregnant or breastfeeding
- Patient has a contained rupture
- Patient has a ruptured aneurysm
- Patient has a dissection in the portion of the aorta intended to be treated
- Obstructive stenting of any or all of the visceral vessels
- Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
- Medical exclusion criteria
- Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
- Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
- Uncorrectable coagulopathy
- Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
- Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
- Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
- Systemic or local infection that may increase the risk of endovascular graft infection
- Baseline creatinine greater than 2.0 mg/dL
- History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
- Anatomical exclusion criteria
- Thrombus or excessive calcification within the neck of the aneurysm
- Anatomy that would not allow maintenance of at least one patent hypogastric artery
- Anatomy that would not allow primary or assisted patency of the left subclavian artery
- Expanded Selection Criteria Subjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tampa General Hospital/ University of South Florida
Tampa, Florida, 33606
University of South Florida - South Tampa Campus
Tampa, Florida, 33606
About this study
Official title: Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study.
The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.
Read the detailed description
This study is a prospective, single-center, non-randomized, single-arm study to evaluate the therapeutic benefit of the TAAA Debranching Stent Graft System. A total of 15 patients will be enrolled in the study.
- 10 subjects total will be treated in the primary study arm
- 5 subjects total will be treated in the expanded selection arm
The duration of the Investigation is anticipated as follows:
- Time to Complete Enrollment: 24 months
- Subject Follow-up Time: 5 years from last subject enrollment
- Total Duration Time: 7 years
The primary objective of the clinical investigation "Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms" is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety acutely (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device acutely (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).
Additionally, the study will assess technical success and treatment success at each follow-up interval.
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Being tested
- TAAA Debranching Stent Graft System
- Keywords
- Vascular, Stent, Graft
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAAA Debranching Stent Graft SystemDevice
The TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
| Study group | Role | What they receive |
|---|---|---|
| Primary study | Experimental | Patients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System. Receives: Device: TAAA Debranching Stent Graft System |
| Expanded selection | Experimental | Patients who fail to meet inclusion criteria for the primary study arm may be enrolled under the expanded selection arm and be treated with the TAAA Debranching Stent Graft System. Receives: Device: TAAA Debranching Stent Graft System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects free from major adverse events
Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke
Measured: 30 days
Proportion of subjects with treatment success
Primary effectiveness outcome: Treatment success is defined as a composite of technical success and freedom from the following: aneurysm enlargement, aneurysm rupture, aneurysm-related mortality, conversion to open repair, secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events
Measured: at 1 year
Secondary outcomes (4)
Proportion of subjects with technical success
Measured: 5 years
Proportion of subjects free from individual components of primary safety endpoint
Individual components of primary safety endpoint include: death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke
Measured: at 30 days
Proportion of subjects free from paraparesis
Free from paraparesis
Measured: 30 days
Proportion of subjects with treatment success
Treatment success includes freedom from: aneurysm enlargement; aneurysm-related mortality; aneurysm rupture; conversion to open repair; secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e. fracture), and patency-related events (i.e. device stenosis or occlusion and embolic events); renal failure; all-cause mortality; endoleaks; device integrity failure (e.g. fracture); patency-related events (i.e. device stenosis or occlusion and embolic events); other device-related events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start19 Dec 2017
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Thoracoabdominal Aortic AneurysmsStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Sanford Health
- Responsible party
- Sponsor
- Investigators
- Murray Shames, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075748
- Sponsor's protocol ID
- IP-01-001 Visceral Manifold
- Status last verified
- Jan 2025
- First submitted
- 24 Feb 2017
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with Sanford Health
Publications
Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
PubMed 24997805Anderson J, Nykamp M, Remund T, Kelly P. Complete endovascular debranching of the aortic arch: A report of two cases. Vascular. 2015 Jun;23(3):310-5. doi: 10.1177/1708538114542174. Epub 2014 Jul 11.
PubMed 25015113Danielson L, Anderson J, Nykamp M, Remund T, Kelly P. Treatment of a massive left femoral arteriovenous malformation using an innovative modular hybrid bifurcated stent graft system. Ann Vasc Surg. 2014 May;28(4):1031.e15-20. doi: 10.1016/j.avsg.2013.07.023. Epub 2013 Oct 31.
PubMed 24184461Narayanan S, Shalhoub J, Karunanithy N, Burfitt N. Primary suture-anastomosis of the Viabahn endoprosthesis to a native artery. J Vasc Surg. 2010 May;51(5):1297-9. doi: 10.1016/j.jvs.2009.12.045. Epub 2010 Mar 19.
PubMed 20303692Donas KP, Lachat M, Rancic Z, Oberkofler C, Pfammatter T, Guber I, Veith FJ, Mayer D. Early and midterm outcome of a novel technique to simplify the hybrid procedures in the treatment of thoracoabdominal and pararenal aortic aneurysms. J Vasc Surg. 2009 Dec;50(6):1280-4. doi: 10.1016/j.jvs.2009.06.053.
PubMed 19958984Oderich GS, Fatima J, Gloviczki P. Stent graft modification with mini-cuff reinforced fenestrations for urgent repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2011 Nov;54(5):1522-6. doi: 10.1016/j.jvs.2011.06.023. Epub 2011 Sep 16.
PubMed 21925826
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT03075748
- Acronym / sponsor ID
- IP-01-001 Visceral Manifold
- Conditions
- Thoracoabdominal Aortic Aneurysms
- Keywords
- Vascular, Stent, Graft
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Medtronic, Sanford Health
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Mar 2017 (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.
The outcomes from prior clinical evaluation of the study device, including successfully treating 99% (84/85) of the intended target vessels and 96% (27/28) limb patency observed at one year, demonstrate the potential benefits of the device. When contrasted with open repair's significant complication rates and branch fenestrated device's significant anatomic and logistic limitations, the potential risk of the proposed novel graft does not outweigh the potential benefit of widened anatomic availability and improved patency rates. Given the potential benefits, the investigators feel that it is justified to expose the target patient population to the potential risk. The non-clinical testing performed by Medtronic and the clinical results reported by Sanford Health show adequate safety of the device to support an early feasibility study.
The investigators would like to perform an early feasibility study under a defined and controlled protocol to collect prospective preliminary safety and device functionality data. The investigators believe an early feasibility study is most appropriate for this novel approach. The limited sample size allows adequate patient data to be collected under a controlled protocol without exposing a large patient population to the risk associated with a novel device design.
Detailed description
This study is a prospective, single-center, non-randomized, single-arm study to evaluate the therapeutic benefit of the TAAA Debranching Stent Graft System. A total of 15 patients will be enrolled in the study.
- 10 subjects total will be treated in the primary study arm
- 5 subjects total will be treated in the expanded selection arm
The duration of the Investigation is anticipated as follows:
- Time to Complete Enrollment: 24 months
- Subject Follow-up Time: 5 years from last subject enrollment
- Total Duration Time: 7 years
The primary objective of the clinical investigation "Visceral Manifold Study for the repair of thoracoabdominal aortic aneurysms" is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety acutely (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device acutely (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).
Additionally, the study will assess technical success and treatment success at each follow-up interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary study | Experimental | Device: TAAA Debranching Stent Graft SystemPatients meeting primary inclusion/exclusion criteria will be enrolled in primary study arm and be treated with the TAAA Debranching Stent Graft System. |
| Expanded selection | Experimental | Device: TAAA Debranching Stent Graft SystemPatients who fail to meet inclusion criteria for the primary study arm may be enrolled under the expanded selection arm and be treated with the TAAA Debranching Stent Graft System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- A patient may be entered into the study if the patient has at least one of the following:
- Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
- Proximal landing zone for the thoracic bifurcation stent graft that has:
- Minimum branch vessel diameter greater than 5 mm
- Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
Key exclusion criteria (28 listed)
- General exclusion
- Patient is a good candidate for and elects for open surgical repair
- Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
- Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
- Unwilling to comply with the follow-up schedule
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 |
|---|---|---|
| TAAA Debranching Stent Graft SystemThe TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold. | Device | Expanded selection, Primary study |
Primary outcome
Proportion of subjects free from major adverse events
Time frame: 30 days
Primary safety outcome: Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke
Proportion of subjects with treatment success
Time frame: at 1 year
Primary effectiveness outcome: Treatment success is defined as a composite of technical success and freedom from the following: aneurysm enlargement, aneurysm rupture, aneurysm-related mortality, conversion to open repair, secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events
4 secondary outcomes
Proportion of subjects with technical success
Time frame: 5 years
Proportion of subjects free from individual components of primary safety endpoint
Time frame: at 30 days
Proportion of subjects free from paraparesis
Time frame: 30 days
Proportion of subjects with treatment success
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Results publication: PubMed 24997805Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.
- Results publication: PubMed 25015113Anderson J, Nykamp M, Remund T, Kelly P. Complete endovascular debranching of the aortic arch: A report of two cases. Vascular. 2015 Jun;23(3):310-5. doi: 10.1177/1708538114542174. Epub 2014 Jul 11.
- Results publication: PubMed 24184461Danielson L, Anderson J, Nykamp M, Remund T, Kelly P. Treatment of a massive left femoral arteriovenous malformation using an innovative modular hybrid bifurcated stent graft system. Ann Vasc Surg. 2014 May;28(4):1031.e15-20. doi: 10.1016/j.avsg.2013.07.023. Epub 2013 Oct 31.
- Results publication: PubMed 20303692Narayanan S, Shalhoub J, Karunanithy N, Burfitt N. Primary suture-anastomosis of the Viabahn endoprosthesis to a native artery. J Vasc Surg. 2010 May;51(5):1297-9. doi: 10.1016/j.jvs.2009.12.045. Epub 2010 Mar 19.
- Results publication: PubMed 19958984Donas KP, Lachat M, Rancic Z, Oberkofler C, Pfammatter T, Guber I, Veith FJ, Mayer D. Early and midterm outcome of a novel technique to simplify the hybrid procedures in the treatment of thoracoabdominal and pararenal aortic aneurysms. J Vasc Surg. 2009 Dec;50(6):1280-4. doi: 10.1016/j.jvs.2009.06.053.
- Results publication: PubMed 21925826Oderich GS, Fatima J, Gloviczki P. Stent graft modification with mini-cuff reinforced fenestrations for urgent repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2011 Nov;54(5):1522-6. doi: 10.1016/j.jvs.2011.06.023. Epub 2011 Sep 16.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with Sanford Health
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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.
Murray Shames, MD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAAA Debranching Stent Graft System in people with Thoracoabdominal Aortic Aneurysms, run by University of South Florida at 2 sites 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 26 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects free from major adverse events (time frame: 30 days). 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 NCT03075748, which also lists 6 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 22 Jan 2025.