Thoracic Aortic DissectionNCT06639243

Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases: a Multicenter Single-Arm Objective Performance Criteria Trial(QYM-Tech Study)

A study testing QYM Technique in people with Thoracic Aortic Dissection and Thoracic Aortic Aneurysm (true Aneurysm), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Background: This study investigates the safety and efficacy of a novel surgical approach combining thoracic endovascular aortic repair (TEVAR) and in situ fenestration reconstruction of supra-aortic branches using the Quick Yielding Modified (QYM) technique. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Thoracic Aortic Dissection, Thoracic Aortic Aneurysm (true Aneurysm), Thoracic Pseudoaneurysm
What is being tested?: QYM Technique
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteChina
Study dates: 1 Jan 2024to 31 Dec 2028
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: Patients between 18 and 80 years of age.
Diagnosis: Patients with the following thoracic aortic conditions confirmed by imaging (CTA):
Thoracic aortic dissection
True thoracic aortic aneurysm
Thoracic pseudoaneurysm
Penetrating aortic ulcer

Show all 16Show fewer

Intramural hematoma
Indication for Treatment: Patients requiring supra-aortic branch vessel reconstruction due to rupture, impending rupture, malperfusion syndrome, rapid expansion, uncontrolled pain, aneurysmal dilation, or for prophylactic reasons.
Proximal Landing Zone: Patients whose proximal stent landing zone is in Zone 0 of the aortic arch.
Aortic Anatomy:
Length of ascending aorta \>4 cm (from the sinotubular junction to the proximal edge of the brachiocephalic artery).
Diameter of ascending aorta between 24 mm and 44 mm.
Access Vessel Anatomy:
Iliac artery diameter ≥7 mm.
Brachiocephalic artery diameter ≤24 mm, and length ≥20 mm.
Informed Consent: Patients who have been informed about the nature of the study and agreed to participate by signing the informed consent form.

Who cannot join

Infection: Patients with systemic infections within the last 3 months.
Recent Neck Surgery: Patients who underwent neck surgery within the past 3 months.
Coronary Involvement: Patients with disease extending to the coronary arteries or aortic valve.
Infectious or Autoimmune Diseases: Patients with conditions such as infectious aortic disease, large vessel vasculitis, or Marfan syndrome (or other connective tissue disorders).
Severe Vascular Conditions: Patients with severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian arteries.
Heart Transplant: Patients who have undergone heart transplantation.

Show all 20Show fewer

Recent Cardiac Events: Patients who had a myocardial infarction or stroke within the last 3 months.
Advanced Heart Failure: Patients with New York Heart Association (NYHA) Class IV heart failure.
Active Gastrointestinal Conditions: Patients with active peptic ulcer disease or upper gastrointestinal bleeding within the past 3 months.
Hematologic Abnormalities:
Leukopenia (white blood cell count \< 3×10⁹/L)
Acute anemia (hemoglobin \< 90 g/L)
Thrombocytopenia (platelet count \< 50×10⁹/L)
History of bleeding disorders or coagulopathy.
Renal Function: Patients with impaired renal function (creatinine \> 265 µmol/L) or those with end-stage renal disease.
Pregnancy or Lactation: Pregnant or breastfeeding women.
Allergy to Contrast Media: Patients with an allergy to the contrast agents used in imaging.
Life Expectancy: Patients with an expected survival of less than 12 months.
Concurrent Research Participation: Patients involved in other drug or device trials.
Other Medical Conditions: Any other disease or condition that, in the opinion of the investigator, may interfere with the endovascular treatment or the patient's ability to participate in the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Vascular Surgery, General Surgery Clinical Center, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai, Shanghai Municipality, 200080

Other trials in China

About this study

Official title: Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases: a Multicenter Single-Arm Objective Performance Criteria Trial (QYM-Tech Study)

Methods: This is a prospective, multicenter, single-arm, interventional study involving 87 patients across 3 centers. Eligible participants are adults aged 18-80 diagnosed with thoracic aortic dissection, thoracic aortic aneurysm (true or pseudo), penetrating aortic ulcer, or intramural hematoma, necessitating supra-aortic branch vessel reconstruction. The surgical protocol involves TEVAR combined with the QYM technique for fenestration and revascularization.

Primary Outcome: The primary endpoint is the incidence of major adverse events (MAE) within 30 days post-operation.

Secondary Outcomes: Secondary endpoints include 12-month aortic treatment success, all-cause mortality, aortic-related mortality, incidence of severe adverse events, occurrence of Type I/III endoleaks, stent graft migration, patency of revascularized branches, and rates of conversion to open surgery or reintervention due to aortic complications.

Inclusion/Exclusion Criteria: Key inclusion criteria include imaging-confirmed thoracic aortic disease requiring endovascular repair with a proximal landing zone in the aortic arch (Zone 0) and suitable anatomical features for stent placement. Patients with recent systemic infections, severe coronary artery involvement, or other significant comorbidities were excluded.

Follow-up and Statistical Analysis: Patients will undergo follow-ups at discharge, 30 days, 6 months, and 12 months post-surgery. Statistical analyses will include descriptive statistics of quantitative and categorical variables, with statistical significance set at a one-sided p-value \< 0.025.

This study aims to provide critical insights into the clinical applicability of the QYM technique, potentially broadening therapeutic options for complex aortic arch diseases.

Conditions: Thoracic Aortic Dissection, Thoracic Aortic Aneurysm (true Aneurysm), Thoracic Pseudoaneurysm, Penetrating Aortic Ulcer, Intramural Hematoma of the Thoracic Aorta
Being tested: QYM Technique
Keywords: Complex aortic arch diseases, Thoracic aortic dissection, Thoracic aortic aneurysm, Penetrating aortic ulcer, Quick Yielding Modified (QYM) technique
Medical subject headings: Dissection, Thoracic Aorta, Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QYM TechniqueDevice
The intervention in this study involves the application of the Quick Yielding Modified (QYM) technique for the treatment of complex aortic arch diseases. This procedure consists of two main components:
1. Thoracic Endovascular Aortic Repair (TEVAR): This minimally invasive procedure utilizes a covered stent graft to exclude the diseased segment of the thoracic aorta, providing immediate protection against rupture and controlling blood flow.
2. In Situ Fenestration and Revascularization of Supra-Aortic Branches: Following TEVAR, the QYM technique includes creating fenestrations in the stent graft to allow for the revascularization of the supra-aortic branches (such as the brachiocephalic, left common carotid, and left subclavian arteries). This is achieved through direct puncture and reconstruction of the branch vessels, ensuring adequate blood flow to these critical arteries while preserving their function.
The combination of these techniques aims to achieve effective treatment out

Study groups in NCT06639243
Study group	Role	What they receive
QTM Technique Treatment Arm	Experimental	In this study, all participants will undergo the Quick Yielding Modified (QYM) technique, which combines thoracic endovascular aortic repair (TEVAR) with in situ fenestration and revascularization of the supra-aortic branches. This technique is designed to treat patients with complex aortic arch diseases, including thoracic aortic dissection, true and pseudoaneurysms, penetrating aortic ulcers, and intramural hematomas. The procedure aims to provide a minimally invasive alternative to open surgery, allowing for the effective reconstruction of the aortic arch and its branches. The study will assess the safety and efficacy of this technique, with key outcomes including the incidence of major adverse events (MAE) and the long-term success of the treatment. Receives: Device: QYM Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation
This primary outcome measure evaluates the safety of the Quick Yielding Modified (QYM) technique by assessing the incidence of major adverse events (MAE) occurring within 30 days following the surgical intervention. Major adverse events include any significant complications that could impact patient health and recovery, such as stroke, myocardial infarction, aortic rupture, organ failure, or death. The goal is to determine the short-term safety profile of the intervention, providing critical information on its clinical viability for patients with complex aortic arch diseases. Data will be collected through patient monitoring, clinical assessments, and medical records during the specified follow-up period.
Measured: 30 days post-operation

Secondary outcomes (11)

Aortic Treatment Success Rate at 12 Months
This secondary outcome measure assesses the effectiveness of the Quick Yielding Modified (QYM) technique by evaluating the rate of successful treatment of the aortic condition at 12 months post-intervention. Treatment success is defined as the absence of significant complications, such as re-intervention or aortic-related adverse events, and the proper functioning of the thoracic stent graft with no significant endoleaks. This measure provides insight into the long-term effectiveness and durability of the surgical intervention.
Measured: Up to 12 months post-operation
All-Cause Mortality
This secondary outcome measure records the rate of all-cause mortality among participants within the study period, allowing for an evaluation of overall patient survival following the intervention. It provides crucial data on the safety and effectiveness of the QYM technique in comparison to the underlying risk of mortality associated with complex aortic arch diseases.
Measured: Up to 12 months post-operation
Aortic-Related Mortality
This secondary outcome measure focuses specifically on mortality directly related to aortic conditions or complications arising from the surgical intervention. This measure helps to evaluate the long-term safety of the QYM technique concerning life-threatening aortic issues.
Measured: Up to 12 months post-operation
Incidence of Severe Adverse Events
This measure tracks the occurrence of severe adverse events in participants, including complications such as stroke, myocardial infarction, and organ failure that are serious enough to require medical intervention. Monitoring these events provides a broader understanding of the risks associated with the procedure.
Measured: Up to 12 months post-operation
Occurrence of Type I or III Endoleaks
This measure evaluates the incidence of Type I or Type III endoleaks following the intervention. Endoleaks are complications that can lead to re-intervention, and monitoring them is critical for assessing the effectiveness of the stent graft placement.
Measured: Up to 12 months post-operation
Rate of Stent Graft Migration
This measure assesses the migration of the thoracic stent graft from its original position within the aorta. Stent migration can affect the success of the procedure and requires careful monitoring to ensure the stent remains securely in place.
Measured: Up to 12 months post-operation
Patency Rate of Revascularized Branch Vessels
This measure evaluates the patency (openness and functionality) of the revascularized supra-aortic branches at follow-up visits. A high patency rate indicates successful reconstruction and blood flow restoration to these vessels.
Measured: Up to 12 months post-operation
Rate of Conversion to Open Surgery or Reintervention Due to Aortic Complications
This measure tracks the incidence of participants who require conversion to open surgery or additional interventions due to complications related to the aorta after the initial procedure. It provides insight into the long-term risks and effectiveness of the QYM technique.
Measured: Up to 12 months post-operation
Incidence of Major Adverse Events (MAE) at 12 Months
This measure assesses the occurrence of major adverse events (MAE) within the 12-month follow-up period. Major adverse events include complications such as stroke, myocardial infarction, aortic rupture, or death. Monitoring the incidence of these events over the long term provides additional data on the safety and durability of the Quick Yielding Modified (QYM) technique.
Measured: 12 months post-operation
Freedom from Aortic Rupture
This outcome tracks the percentage of participants who remain free from aortic rupture following the QYM technique over the course of 12 months. Aortic rupture is a life-threatening event, and the goal is to assess whether the intervention effectively prevents this complication in patients with complex aortic arch diseases.
Measured: 12 months post-operation
Freedom from Reintervention
This measure evaluates the percentage of participants who do not require additional surgical or endovascular interventions on the thoracic aorta or supra-aortic branches after the initial procedure. The goal is to assess the long-term effectiveness of the QYM technique and its ability to prevent the need for further treatments.
Measured: 12 months post-operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202431 Dec 2028

First posted15 Oct 2024
Study start1 Jan 2024
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Thoracic Aortic DissectionStudies of the same condition, open and under way.
More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 87 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06639243
Sponsor's protocol ID: Qingwei Ding
Status last verified: Oct 2024
First submitted: 10 Oct 2024
Last updated: 15 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Shu C, Fan B, Luo M, Li Q, Fang K, Li M, Li X, He H, Wang T, Yang C, Xue Y, Gao H, Zhao J. Endovascular treatment for aortic arch pathologies: chimney, on-the-table fenestration, and in-situ fenestration techniques. J Thorac Dis. 2020 Apr;12(4):1437-1448. doi: 10.21037/jtd.2020.03.10.
PubMed 32395281
Matsuda H, Fukuda T, Iritani O, Nakazawa T, Tanaka H, Sasaki H, Minatoya K, Ogino H. Spinal cord injury is not negligible after TEVAR for lower descending aorta. Eur J Vasc Endovasc Surg. 2010 Feb;39(2):179-86. doi: 10.1016/j.ejvs.2009.11.014. Epub 2009 Dec 3.
PubMed 19962330
Wang J, Jin T, Chen B, Pan Y, Shao C. Systematic review and meta-analysis of current evidence in endograft therapy vs medical treatment for uncomplicated type B aortic dissection. J Vasc Surg. 2022 Oct;76(4):1099-1108.e3. doi: 10.1016/j.jvs.2022.03.876. Epub 2022 Apr 4.
PubMed 35390485

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quick Yielding Modified Short-Distance Fenestration Technique for the Treatment of Complex Aortic Arch Diseases: a Multicenter Single-Arm Objective Performance Criteria Trial (QYM-Tech Study)
ClinicalTrials.gov ID: NCT06639243
Acronym / sponsor ID: Qingwei Ding
Conditions: Thoracic Aortic Dissection, Thoracic Aortic Aneurysm (true Aneurysm), Thoracic Pseudoaneurysm, Penetrating Aortic Ulcer, Intramural Hematoma of the Thoracic Aorta
Keywords: Complex aortic arch diseases, Thoracic aortic dissection, Thoracic aortic aneurysm, Penetrating aortic ulcer, Quick Yielding Modified (QYM) technique
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 87 participants (estimated)
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 1 Jan 2024 (actual)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 15 Oct 2024 (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.

Primary Outcome: The primary endpoint is the incidence of major adverse events (MAE) within 30 days post-operation.

This study aims to provide critical insights into the clinical applicability of the QYM technique, potentially broadening therapeutic options for complex aortic arch diseases.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
QTM Technique Treatment Arm	Experimental	Device: QYM TechniqueIn this study, all participants will undergo the Quick Yielding Modified (QYM) technique, which combines thoracic endovascular aortic repair (TEVAR) with in situ fenestration and revascularization of the supra-aortic branches. This technique is designed to treat patients with complex aortic arch diseases, including thoracic aortic dissection, true and pseudoaneurysms, penetrating aortic ulcers, and intramural hematomas. The procedure aims to provide a minimally invasive alternative to open surgery, allowing for the effective reconstruction of the aortic arch and its branches. The study will assess the safety and efficacy of this technique, with key outcomes including the incidence of major adverse events (MAE) and the long-term success of the treatment.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Age: Patients between 18 and 80 years of age.
Diagnosis: Patients with the following thoracic aortic conditions confirmed by imaging (CTA):
Indication for Treatment: Patients requiring supra-aortic branch vessel reconstruction due to rupture, impending rupture, malperfusion syndrome, rapid expansion, uncontrolled pain, aneurysmal dilation, or for prophylactic reasons.
Proximal Landing Zone: Patients whose proximal stent landing zone is in Zone 0 of the aortic arch.
Aortic Anatomy:

Key exclusion criteria (20 listed)

Infection: Patients with systemic infections within the last 3 months.
Recent Neck Surgery: Patients who underwent neck surgery within the past 3 months.
Coronary Involvement: Patients with disease extending to the coronary arteries or aortic valve.
Infectious or Autoimmune Diseases: Patients with conditions such as infectious aortic disease, large vessel vasculitis, or Marfan syndrome (or other connective tissue disorders).
Severe Vascular Conditions: Patients with severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian arteries.

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
QYM TechniqueThe intervention in this study involves the application of the Quick Yielding Modified (QYM) technique for the treatment of complex aortic arch diseases. This procedure consists of two main components: 1. Thoracic Endovascular Aortic Repair (TEVAR): This minimally invasive procedure utilizes a covered stent graft to exclude the diseased segment of the thoracic aorta, providing immediate protection against rupture and controlling blood flow. 2. In Situ Fenestration and Revascularization of Supra-Aortic Branches: Following TEVAR, the QYM technique includes creating fenestrations in the stent graft to allow for the revascularization of the supra-aortic branches (such as the brachiocephalic, left common carotid, and left subclavian arteries). This is achieved through direct puncture and reconstruction of the branch vessels, ensuring adequate blood flow to these critical arteries while preserving their function. The combination of these techniques aims to achieve effective treatment out	Device	QTM Technique Treatment Arm

Primary outcome

Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation
Time frame: 30 days post-operation
This primary outcome measure evaluates the safety of the Quick Yielding Modified (QYM) technique by assessing the incidence of major adverse events (MAE) occurring within 30 days following the surgical intervention. Major adverse events include any significant complications that could impact patient health and recovery, such as stroke, myocardial infarction, aortic rupture, organ failure, or death. The goal is to determine the short-term safety profile of the intervention, providing critical information on its clinical viability for patients with complex aortic arch diseases. Data will be collected through patient monitoring, clinical assessments, and medical records during the specified follow-up period.

11 secondary outcomes

Aortic Treatment Success Rate at 12 Months
Time frame: Up to 12 months post-operation
All-Cause Mortality
Time frame: Up to 12 months post-operation
Aortic-Related Mortality
Time frame: Up to 12 months post-operation
Incidence of Severe Adverse Events
Time frame: Up to 12 months post-operation
Occurrence of Type I or III Endoleaks
Time frame: Up to 12 months post-operation
Rate of Stent Graft Migration
Time frame: Up to 12 months post-operation
Patency Rate of Revascularized Branch Vessels
Time frame: Up to 12 months post-operation
Rate of Conversion to Open Surgery or Reintervention Due to Aortic Complications
Time frame: Up to 12 months post-operation
Incidence of Major Adverse Events (MAE) at 12 Months
Time frame: 12 months post-operation
Freedom from Aortic Rupture
Time frame: 12 months post-operation
Freedom from Reintervention
Time frame: 12 months post-operation

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 15 Oct 2024.
Background: PubMed 32395281Shu C, Fan B, Luo M, Li Q, Fang K, Li M, Li X, He H, Wang T, Yang C, Xue Y, Gao H, Zhao J. Endovascular treatment for aortic arch pathologies: chimney, on-the-table fenestration, and in-situ fenestration techniques. J Thorac Dis. 2020 Apr;12(4):1437-1448. doi: 10.21037/jtd.2020.03.10.
Background: PubMed 19962330Matsuda H, Fukuda T, Iritani O, Nakazawa T, Tanaka H, Sasaki H, Minatoya K, Ogino H. Spinal cord injury is not negligible after TEVAR for lower descending aorta. Eur J Vasc Endovasc Surg. 2010 Feb;39(2):179-86. doi: 10.1016/j.ejvs.2009.11.014. Epub 2009 Dec 3.
Background: PubMed 35390485Wang J, Jin T, Chen B, Pan Y, Shao C. Systematic review and meta-analysis of current evidence in endograft therapy vs medical treatment for uncomplicated type B aortic dissection. J Vasc Surg. 2022 Oct;76(4):1099-1108.e3. doi: 10.1016/j.jvs.2022.03.876. Epub 2022 Apr 4.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 20 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 15 Oct 2024. 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 China. 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?

Incidence of Major Adverse Events (MAE) Within 30 Days Post-Operation (time frame: 30 days post-operation). 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 NCT06639243, which also lists 3 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 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.