Dissecting Aneurysm of Cerebral ArteryVBDAs ChinaNCT06541106
Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
An observational study of Dissecting Aneurysm of Cerebral Artery, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The incidence of vertebrobasilar dissecting aneurysms (VBDAs) is about 1/100,000~1.5/100,000, and it is one of the most important causes of stroke in young and middle-aged people. In recent years, with the development of medical imaging technology, the detection rate of this disease has been increasing year by year. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dissecting Aneurysm of Cerebral Artery
- What is being tested?
- Multi-disciplinary assessment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 1 Jan 2032
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Who may be able to join
- Age 18-80 years old;
- Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Who cannot join
- Patients did not undergo a cranial MRI;
- Missing critical clinical baseline;
- Missing pre-treatment imaging;
- Receiving microsurgery;
- The combination of other serious diseases during diagnosis will significantly affect the follow-up of patients;
- CT/MRI shows intracranial hemorrhage or subarachnoid hemorrhage (SWI microbleeds are ignored).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010
Ming Lv, MD,PhD, +8613701376177, dragontiger@163.com
Linggen Dong, MD, +8618844738529, donglinggen@163.com
About this study
The incidence of vertebrobasilar dissecting aneurysms (VBDAs) is about 1/100,000~1.5/100,000, and it is one of the most important causes of stroke in young and middle-aged people. In recent years, with the development of medical imaging technology, the detection rate of this disease has been increasing year by year. The natural prognosis of VBDAs is complex and varied, with uncertainty: (1) it may have a benign course, and the imaging follow-up may show that the diseased vessels are repaired and improved or remain stable for a long period of time; (2) it may present with ischemic stroke caused by hemodynamic alteration or thromboembolism, which may result in severe neurological impairment; (3) it may occur as a result of rupture of aneurysms leading to subarachnoid hemorrhage, endangering the patient's life; (4) progressive enlargement of VBDAs causing occupying effects, which may be manifested as headache in mild cases, or hemiplegia of limbs and choking on drinking water in severe cases. Up to now, there is a lack of objective and uniform diagnostic and therapeutic guidelines for the natural regression of VBDAs and the benefits of surgery, and the treatment is mostly empirical, which makes it difficult to accurately determine the clinical prognosis of VBDAs and formulate appropriate treatment strategies.
Therefore, against the above background, we designed the present study. This study was a multicenter, prospective, registry study. We enrolled patients with unruptured VBDAs who met the inclusion and exclusion criteria, and a multi-disciplinary team formulated the treatment modalities for the patients, which were categorized into the conservative observation group, the stent-assisted coiling group, and the flow diverter group. The aim of our study was to investigate the effects of different treatment modalities on the prognosis of patients with VBDAs, as well as to stratify the risk factors of the patients, to explore the individualized treatment modalities of the patients, and to improve the diagnosis and treatment of this clinically refractory cerebrovascular disease.
- Conditions
- Dissecting Aneurysm of Cerebral Artery
- Being tested
- Multi-disciplinary assessment
- Keywords
- Vertebrobasilar dissecting aneurysms, Endovascular treatment, Prognosis, Hemorrhagic stroke
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-disciplinary assessmentOther
- Comprehensive evaluation was performed by multi-disciplinary experts to assess the prognosis of unruptured VBDAs and develop appropriate treatment strategies.
- Preoperative cranial MRI, CTA, DSA and other imaging tests were used to determine the aneurysm site, morphology, size, presence of compression symptoms, and whether it was accompanied by an intramural hematoma.
| Study group | Role | What they receive |
|---|---|---|
| Conservative management group | Patients with unruptured VBDAs did not receive any interventional therapy (including endovascular therapy and microsurgery). Receives: Other: Multi-disciplinary assessment | |
| Stent-assisted coiling group | Patients with unruptured VBDAs receive common stent and coils embolization. | |
| Flow diverter group | Patients with unruptured VBDAs receive flow diverter treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor prognosis
Defined as an mRS score of 3-6.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm rupture
Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Secondary outcomes (6)
Ischemic stroke
Ischemic stroke refer to in-stent thrombosis, transient ischemic attack, or cerebral infarction associated with the treated vascular area.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Compression symptom
Compression symptoms refer to cranial neuropathy or brainstem symptoms associated with aneurysm compression.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
VBDA-related death
Patients died during hospitalization or follow-up and were associated with VBDA. The causes of death were categorized as: aneurysm rupture, ischemic stroke, and compression symptoms.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Improvement of neurological dysfunction
The modified Rankin score was used to evaluate neurological dysfunction: Grade 0, completely asymptomatic; Grade 1, able to complete all daily duties and activities despite symptoms, but without obvious dysfunction; Grade 2, mildly disabled, unable to complete all activities before illness, but does not need help, can take care of themself; Grade 3, moderately disabled, requires some help, but does not need help while walking; Grade 4, severely disabled, unable to walk independently, unable to meet their own needs without help from others; Grade 5, severely disabled, bedridden, incontinence, requiring continuous care And attention; Grade 6, death.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Rate of complete occlusion of aneurysms
Complete occlusion of the aneurysm was confirmed by DSA, and then the rate of complete occlusion was compared between the groups.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm recanalization
Aneurysm recanalization was confirmed by DSA, and then the rate of aneurysm recanalization was compared between the groups.
Measured: 6 months, 1 year, 3 years, and 5 years after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2011
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dissecting Aneurysm of Cerebral ArteryStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University International Hospital, The First People's Hospital of Lianyungang, Chinese PLA General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Yichang Central People's Hospital, Taihe Hospital, Liaocheng People's Hospital, Binzhou People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Beijing Aerospace General Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, The Second Hospital of Hebei Medical University, Dalian Municipal Central Hospital, Shijiazhuang Third Hospital, Affiliated Hospital of Chengde Medical University, Xingtai People's Hospital, Taian City Central Hospital, Wuhan Brain Hospital
- Responsible party
- Principal investigator, Ming Lv, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06541106
- Sponsor's protocol ID
- VBDAs China
- Acronym
- VBDAs China
- Status last verified
- Nov 2025
- First submitted
- 2 Aug 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang LT, Zhang M, Tong X. Cerebral revascularization for complex vertebrobasilar artery dissecting aneurysms. Neurosurg Rev. 2024 Apr 5;47(1):138. doi: 10.1007/s10143-024-02365-5.
PubMed 38578572Amoukhteh M, Hassankhani A, Valizadeh P, Jannatdoust P, Ghozy S, Kobeissi H, Kallmes DF. Flow diverters in the treatment of intracranial dissecting aneurysms: a systematic review and meta-analysis of safety and efficacy. J Neurointerv Surg. 2024 Sep 17;16(10):1005-1012. doi: 10.1136/jnis-2023-021117.
PubMed 38212103Dmytriw AA, Alrashed A, Enriquez-Marulanda A, Medhi G, Mendes Pereira V. Unruptured Intradural Posterior Circulation Dissecting/Fusiform Aneurysms Natural History and Treatment Outcome. Interv Neuroradiol. 2023 Feb;29(1):56-62. doi: 10.1177/15910199211068673. Epub 2021 Dec 22.
PubMed 34935531Nakatomi H, Kiyofuji S, Ono H, Tanaka M, Kamiyama H, Takizawa K, Imai H, Saito N, Shiokawa Y, Morita A, Flemming KD, Link MJ. Giant Fusiform and Dolichoectatic Aneurysms of the Basilar Trunk and Vertebrobasilar Junction-Clinicopathological and Surgical Outcome. Neurosurgery. 2020 Dec 15;88(1):82-95. doi: 10.1093/neuros/nyaa317.
PubMed 32745190Adeeb N, Ogilvy CS, Griessenauer CJ, Thomas AJ. Expanding the Indications for Flow Diversion: Treatment of Posterior Circulation Aneurysms. Neurosurgery. 2020 Jan 1;86(Suppl 1):S76-S84. doi: 10.1093/neuros/nyz344.
PubMed 31838535Cho DY, Kim BS, Choi JH, Park YK, Shin YS. The Fate of Unruptured Intracranial Vertebrobasilar Dissecting Aneurysm with Brain Stem Compression According to Different Treatment Modalities. AJNR Am J Neuroradiol. 2019 Nov;40(11):1924-1931. doi: 10.3174/ajnr.A6252. Epub 2019 Oct 10.
PubMed 31601577Frisoli FA, Srinivasan VM, Catapano JS, Rudy RF, Nguyen CL, Jonzzon S, Korson C, Karahalios K, Lawton MT. Vertebrobasilar dissecting aneurysms: microsurgical management in 42 patients. J Neurosurg. 2021 Dec 10;137(2):393-401. doi: 10.3171/2021.9.JNS21397. Print 2022 Aug 1.
PubMed 34891141Ahn SS, Kim BM, Suh SH, Kim DJ, Kim DI, Shin YS, Ha SY, Kwon YS. Spontaneous symptomatic intracranial vertebrobasilar dissection: initial and follow-up imaging findings. Radiology. 2012 Jul;264(1):196-202. doi: 10.1148/radiol.12112331. Epub 2012 May 1.
PubMed 22550310Zhang Y, Tian Z, Sui B, Wang Y, Liu J, Li M, Li Y, Jiang C, Yang X. Endovascular Treatment of Spontaneous Intracranial Fusiform and Dissecting Aneurysms: Outcomes Related to Imaging Classification of 309 Cases. World Neurosurg. 2017 Feb;98:444-455. doi: 10.1016/j.wneu.2016.11.074. Epub 2016 Nov 24.
PubMed 27890754Sonmez O, Brinjikji W, Murad MH, Lanzino G. Deconstructive and Reconstructive Techniques in Treatment of Vertebrobasilar Dissecting Aneurysms: A Systematic Review and Meta-Analysis. AJNR Am J Neuroradiol. 2015 Jul;36(7):1293-8. doi: 10.3174/ajnr.A4360. Epub 2015 May 7.
PubMed 25953763
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
- ClinicalTrials.gov ID
- NCT06541106
- Acronym / sponsor ID
- VBDAs China / VBDAs China
- Conditions
- Dissecting Aneurysm of Cerebral Artery
- Keywords
- Vertebrobasilar dissecting aneurysms, Endovascular treatment, Prognosis, Hemorrhagic stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital, Peking University International Hospital, The First People's Hospital of Lianyungang, Chinese PLA General Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Yichang Central People's Hospital, Taihe Hospital, Liaocheng People's Hospital, Binzhou People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Beijing Aerospace General Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, The Second Hospital of Hebei Medical University, Dalian Municipal Central Hospital, Shijiazhuang Third Hospital, Affiliated Hospital of Chengde Medical University, Xingtai People's Hospital, Taian City Central Hospital, Wuhan Brain Hospital
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 7 Aug 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.
The incidence of vertebrobasilar dissecting aneurysms (VBDAs) is about 1/100,000~1.5/100,000, and it is one of the most important causes of stroke in young and middle-aged people. In recent years, with the development of medical imaging technology, the detection rate of this disease has been increasing year by year. The natural prognosis of VBDAs is complex and varied, with uncertainty: (1) it may have a benign course, and the imaging follow-up may show that the diseased vessels are repaired and improved or remain stable for a long period of time; (2) it may present with ischemic stroke caused by hemodynamic alteration or thromboembolism, which may result in severe neurological impairment; (3) it may occur as a result of rupture of aneurysms leading to subarachnoid hemorrhage, endangering the patient's life; (4) progressive enlargement of VBDAs causing occupying effects, which may be manifested as headache in mild cases, or hemiplegia of limbs and choking on drinking water in severe cases. Up to now, there is a lack of objective and uniform diagnostic and therapeutic guidelines for the natural regression of VBDAs and the benefits of surgery, and the treatment is mostly empirical, which makes it difficult to accurately determine the clinical prognosis of VBDAs and formulate appropriate treatment strategies.
Therefore, against the above background, we designed the present study. This study was a multicenter, prospective, registry study. We enrolled patients with unruptured VBDAs who met the inclusion and exclusion criteria, and a multi-disciplinary team formulated the treatment modalities for the patients, which were categorized into the conservative observation group, the stent-assisted coiling group, and the flow diverter group. The aim of our study was to investigate the effects of different treatment modalities on the prognosis of patients with VBDAs, as well as to stratify the risk factors of the patients, to explore the individualized treatment modalities of the patients, and to improve the diagnosis and treatment of this clinically refractory cerebrovascular disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative management group | – | Other: Multi-disciplinary assessmentPatients with unruptured VBDAs did not receive any interventional therapy (including endovascular therapy and microsurgery). |
| Stent-assisted coiling group | – | –Patients with unruptured VBDAs receive common stent and coils embolization. |
| Flow diverter group | – | –Patients with unruptured VBDAs receive flow diverter treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Key inclusion criteria (2 listed)
- Age 18-80 years old;
- Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
Key exclusion criteria (6 listed)
- Patients did not undergo a cranial MRI;
- Missing critical clinical baseline;
- Missing pre-treatment imaging;
- Receiving microsurgery;
- The combination of other serious diseases during diagnosis will significantly affect the follow-up of patients;
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 |
|---|---|---|
| Multi-disciplinary assessment1. Comprehensive evaluation was performed by multi-disciplinary experts to assess the prognosis of unruptured VBDAs and develop appropriate treatment strategies. 2. Preoperative cranial MRI, CTA, DSA and other imaging tests were used to determine the aneurysm site, morphology, size, presence of compression symptoms, and whether it was accompanied by an intramural hematoma. | Other | Conservative management group |
Primary outcome
Poor prognosis
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Defined as an mRS score of 3-6.
Aneurysm rupture
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.
6 secondary outcomes
Ischemic stroke
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Compression symptom
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
VBDA-related death
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Improvement of neurological dysfunction
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Rate of complete occlusion of aneurysms
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
Aneurysm recanalization
Time frame: 6 months, 1 year, 3 years, and 5 years after treatment.
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 28 Nov 2025.
- Background: PubMed 38578572Huang LT, Zhang M, Tong X. Cerebral revascularization for complex vertebrobasilar artery dissecting aneurysms. Neurosurg Rev. 2024 Apr 5;47(1):138. doi: 10.1007/s10143-024-02365-5.
- Background: PubMed 38212103Amoukhteh M, Hassankhani A, Valizadeh P, Jannatdoust P, Ghozy S, Kobeissi H, Kallmes DF. Flow diverters in the treatment of intracranial dissecting aneurysms: a systematic review and meta-analysis of safety and efficacy. J Neurointerv Surg. 2024 Sep 17;16(10):1005-1012. doi: 10.1136/jnis-2023-021117.
- Background: PubMed 34935531Dmytriw AA, Alrashed A, Enriquez-Marulanda A, Medhi G, Mendes Pereira V. Unruptured Intradural Posterior Circulation Dissecting/Fusiform Aneurysms Natural History and Treatment Outcome. Interv Neuroradiol. 2023 Feb;29(1):56-62. doi: 10.1177/15910199211068673. Epub 2021 Dec 22.
- Background: PubMed 32745190Nakatomi H, Kiyofuji S, Ono H, Tanaka M, Kamiyama H, Takizawa K, Imai H, Saito N, Shiokawa Y, Morita A, Flemming KD, Link MJ. Giant Fusiform and Dolichoectatic Aneurysms of the Basilar Trunk and Vertebrobasilar Junction-Clinicopathological and Surgical Outcome. Neurosurgery. 2020 Dec 15;88(1):82-95. doi: 10.1093/neuros/nyaa317.
- Background: PubMed 31838535Adeeb N, Ogilvy CS, Griessenauer CJ, Thomas AJ. Expanding the Indications for Flow Diversion: Treatment of Posterior Circulation Aneurysms. Neurosurgery. 2020 Jan 1;86(Suppl 1):S76-S84. doi: 10.1093/neuros/nyz344.
- Background: PubMed 31601577Cho DY, Kim BS, Choi JH, Park YK, Shin YS. The Fate of Unruptured Intracranial Vertebrobasilar Dissecting Aneurysm with Brain Stem Compression According to Different Treatment Modalities. AJNR Am J Neuroradiol. 2019 Nov;40(11):1924-1931. doi: 10.3174/ajnr.A6252. Epub 2019 Oct 10.
- Background: PubMed 34891141Frisoli FA, Srinivasan VM, Catapano JS, Rudy RF, Nguyen CL, Jonzzon S, Korson C, Karahalios K, Lawton MT. Vertebrobasilar dissecting aneurysms: microsurgical management in 42 patients. J Neurosurg. 2021 Dec 10;137(2):393-401. doi: 10.3171/2021.9.JNS21397. Print 2022 Aug 1.
- Background: PubMed 22550310Ahn SS, Kim BM, Suh SH, Kim DJ, Kim DI, Shin YS, Ha SY, Kwon YS. Spontaneous symptomatic intracranial vertebrobasilar dissection: initial and follow-up imaging findings. Radiology. 2012 Jul;264(1):196-202. doi: 10.1148/radiol.12112331. Epub 2012 May 1.
- Background: PubMed 27890754Zhang Y, Tian Z, Sui B, Wang Y, Liu J, Li M, Li Y, Jiang C, Yang X. Endovascular Treatment of Spontaneous Intracranial Fusiform and Dissecting Aneurysms: Outcomes Related to Imaging Classification of 309 Cases. World Neurosurg. 2017 Feb;98:444-455. doi: 10.1016/j.wneu.2016.11.074. Epub 2016 Nov 24.
- Background: PubMed 25953763Sonmez O, Brinjikji W, Murad MH, Lanzino G. Deconstructive and Reconstructive Techniques in Treatment of Vertebrobasilar Dissecting Aneurysms: A Systematic Review and Meta-Analysis. AJNR Am J Neuroradiol. 2015 Jul;36(7):1293-8. doi: 10.3174/ajnr.A4360. Epub 2015 May 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dissecting Aneurysm of Cerebral Artery, run by Beijing Tiantan Hospital at 1 site in China.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Nov 2025. 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?
Contact Linggen Dong, MD (+8613701376177, donglinggen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor prognosis (time frame: 6 months, 1 year, 3 years, and 5 years after treatment.). 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 NCT06541106, which also lists 10 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 28 Nov 2025.