Non-acute Carotid Artery OcclusionASCENTNCT07803419
Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion
A study testing Guideline-Based Best Medical Treatment, Endovascular Recanalization With Proximal Balloon Protection and Endovascular Recanalization Without Proximal Protection in people with Non-acute Carotid Artery Occlusion and Cognitive Impairment, run by Dapeng Mo at 1 site in China.
Trial summary
This study is a multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the safety and potential efficacy of endovascular recanalization strategies in patients with symptomatic non-acute carotid artery occlusion and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-acute Carotid Artery Occlusion, Cognitive Impairment
- What is being tested?
- Guideline-Based Best Medical Treatment, Endovascular Recanalization With Proximal Balloon Protection and Endovascular Recanalization Without Proximal Protection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 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
- The age ranged from 18 to 80 years
- Unilateral carotid artery occlusion confirmed by CTA or DSA (excluding anterior and middle cerebral artery occlusion)
- Complete 3T-MRI within 1-3 days before operation
- The time of carotid artery occlusion was more than 24h (confirmed by imaging or according to the patient's condition), and not more than 3 months
- Ischemic stroke or TIA related to occluded vessels existed in the past 3 months, and the last ischemic event was > 2 weeks; and there was cognitive impairment, MoCA score ≤ 25 after education correction
- Imaging confirmed that there was hypoperfusion in the ipsilateral cerebral hemisphere of carotid artery occlusion, which met at least any of the following requirements:
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- ①Head CT perfusion imaging showed low perfusion in the lesion vascular area (CBF decreased by 30% compared with contralateral perfusion)
- ②ASITN/SIR collateral circulation score based on DSA < 3 points
- ③Cerebral infarction with hemodynamic abnormalities confirmed by head MRI (such as watershed infarction)
- Sign the informed consent form
Who cannot join
- There was severe neurological dysfunction (mRS ≥ 4) before enrollment
- The ipsilateral common carotid artery was occluded, or the ipsilateral middle cerebral artery was severely stenosed or occluded
- Non atherosclerotic occlusion (such as vasculitis, moyamoya disease, etc.)
- Patients with massive cerebral infarction (infarction volume based on MRI-DWI/ADC is more than 70ml)
- Untreated intracranial aneurysms, intracranial tumors (except meningiomas) or any intracranial vascular malformations
- Evidence of cardiogenic embolism
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- Allergic to heparin, aspirin, clopidogrel, statins, metals, anesthetics, contrast agents, or unable to tolerate general anesthesia surgery
- Any history of intracranial hemorrhage within 30 days (including cerebral parenchyma, ventricle, subarachnoid hemorrhage, subdural or epidural)
- History of primary cerebral parenchymal hemorrhage
- There are contraindications to antiplatelet drugs
- There are coagulation disorders and systemic bleeding
- Thrombocytopenia (<100 × 10⁹/L)
- Uncontrolled severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)
- Severe coronary heart disease, severe liver injury (AST or ALT more than 3 times the normal value), liver cirrhosis and severe renal insufficiency (creatinine>177 μmol/L) were observed
- Major surgical operations within 30 days or in the next 90 days
- It is known that patients with dementia, cognitive impairment caused by other reasons or mental diseases cannot complete the assessment of neurological and cognitive functions
- There are cerebral infarction that clearly involves the key brain areas of cognition, or there are neurological deficits that affect the accuracy of cognitive function assessment, such as severe aphasia, neglect, and audiovisual impairment. According to the judgment of the researchers, the decline of cognitive function is mainly caused by irreversible brain tissue injury
- The expected survival time of patients with other diseases was less than 2 years
- Pregnancy or lactation
- Patients have been included in other studies, which is in conflict with this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion - A Multicenter, Prospective, Blind Endpoint, Pilot， Randomized Controlled Trial
This study is a multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the safety and potential efficacy of endovascular recanalization strategies in patients with symptomatic non-acute carotid artery occlusion and cognitive impairment. Eligible participants will be randomly assigned to best medical treatment alone, endovascular recanalization without proximal protection plus best medical treatment, or endovascular recanalization with proximal balloon protection plus best medical treatment. The study will assess whether endovascular recanalization improves cognitive function and whether proximal protection reduces procedure-related new ischemic lesions on diffusion-weighted magnetic resonance imaging.
Read the detailed description
Symptomatic non-acute carotid artery occlusion may lead to recurrent ischemic events, chronic cerebral hypoperfusion, and cognitive decline. Best medical treatment is the standard foundation of care, but selected patients with persistent hypoperfusion may remain at risk. Endovascular recanalization may improve cerebral perfusion, but procedure-related distal embolization and new ischemic lesions remain important safety concerns.
Eligible patients will have symptomatic non-acute carotid artery occlusion, ipsilateral cerebral hypoperfusion, and baseline cognitive impairment defined by an education-adjusted Montreal Cognitive Assessment score of 25 or lower. Participants will be randomized in a 1:1:1 ratio to best medical treatment alone, endovascular recanalization without proximal protection plus best medical treatment, or endovascular recanalization with proximal balloon protection plus best medical treatment.
In the proximal protection group, a balloon guide catheter will be used to achieve proximal flow arrest or flow control during key procedural steps. In the unprotected endovascular group, recanalization will be performed without routine proximal balloon flow control. The primary safety outcome is the number of new ischemic lesions on diffusion-weighted magnetic resonance imaging within 24 to 72 hours. The primary efficacy outcome is the change in Montreal Cognitive Assessment score from baseline to 6 months.
- Being tested
- Guideline-Based Best Medical Treatment, Endovascular Recanalization With Proximal Balloon Protection, Endovascular Recanalization Without Proximal Protection
- Keywords
- Non-acute Carotid Artery Occlusion, Chronic Carotid Artery Occlusion, Symptomatic Carotid Artery Occlusion, Endovascular Recanalization, Balloon Guide Catheter, Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guideline-Based Best Medical TreatmentOther
Guideline-based best medical treatment includes antiplatelet therapy and management of vascular risk factors, such as blood pressure, lipid, glucose, and lifestyle management, according to current clinical practice.
Endovascular Recanalization With Proximal Balloon ProtectionProcedure or surgery
Endovascular recanalization will be performed using neurointerventional techniques. A balloon guide catheter will be positioned proximally to achieve temporary flow arrest or flow control during key lesion-treatment steps, with the aim of reducing distal migration of thrombus or plaque debris.
Endovascular Recanalization Without Proximal ProtectionProcedure or surgery
Endovascular recanalization will be performed using standard neurointerventional techniques without routine proximal balloon flow arrest or flow control.
| Study group | Role | What they receive |
|---|---|---|
| Best Medical Treatment | Active comparator | Participants in this arm will receive guideline-based best medical treatment, including antiplatelet therapy and management of vascular risk factors. Receives: Other: Guideline-Based Best Medical Treatment |
| Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical Treatment | Experimental | Participants in this arm will undergo endovascular recanalization with proximal balloon protection in addition to guideline-based best medical treatment. Proximal balloon protection will be used to achieve temporary proximal flow arrest or flow control during key procedural steps. Receives: Procedure: Endovascular Recanalization With Proximal Balloon Protection |
| Endovascular Recanalization Without Proximal Protection Plus Best Medical Treatment | Experimental | Participants in this arm will undergo endovascular recanalization without routine proximal balloon flow control, in addition to guideline-based best medical treatment. Receives: Procedure: Endovascular Recanalization Without Proximal Protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization
Measured: 6 months after randomization
Total number of new infarcts on DWI-MRI within 24-72 hours after randomization
Total number of new infarcts on DWI-MRI within 24-72 hours after randomization
Measured: Within 24-72h after randomization
Secondary outcomes (15)
The volume of new infarcts 24-72 hours after randomization
The volume of new infarcts 24-72 hours after randomization
Measured: 24-72 hours after randomization
Incidence of new infarcts 24-72 hours after randomization
Incidence of new infarcts 24-72 hours after randomization
Measured: 24-72 hours after randomization
Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels)
Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels)
Measured: 24-72 hours after randomization
location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved)
location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved)
Measured: 24-72 hours after randomization
The average number of new infarcts per enrolled patient 24-72 hours after randomization
The average number of new infarcts per enrolled patient 24-72 hours after randomization
Measured: 24-72 hours after randomization
The average number of new infarcts in the responsible vessels of each enrolled patient 24-72 hours after randomization
The average number of new infarcts in the responsible vessels of each enrolled patient 24-72 hours after randomization
Measured: 24-72 hours after randomization
The average number of new infarcts beyond the scope of responsible vessels per enrolled patient 24-72 hours after randomization
The average number of new infarcts beyond the scope of responsible vessels per enrolled patient 24-72 hours after randomization
Measured: 24-72 hours after randomization
The rate of symptomatic intracranial hemorrhage (SICH) within 72 hours after randomization (Heidelberg bleeding classification)
The rate of symptomatic intracranial hemorrhage (SICH) within 72 hours after randomization (Heidelberg bleeding classification)
Measured: Within 72 hours after randomization
Operation related complications within 72 hours after randomization (operation related complications, defined as arterial dissection, new area embolism, cavernous sinus fistula, arterial perforation, subarachnoid hemorrhage, etc.)
Operation related complications within 72 hours after randomization (operation related complications, defined as arterial dissection, new area embolism, cavernous sinus fistula, arterial perforation, subarachnoid hemorrhage, etc.)
Measured: Within 72 hours after randomization
Any stroke (hemorrhagic or ischemic) or death within 30 days after randomization
Any stroke (hemorrhagic or ischemic) or death within 30 days after randomization
Measured: Within 30 days after randomization
Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 6 months after randomization
Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 6 months after randomization
Measured: Within 6 months after randomization
Restenosis or re-occlusion of target vessels confirmed by CTA/DSA 6 months after randomization
Restenosis or re-occlusion of target vessels confirmed by CTA/DSA 6 months after randomization
Measured: 6 months after randomization
The changes of cognitive function (MMSE score) compared with baseline 6 months after randomization
The changes of cognitive function (MMSE score) compared with baseline 6 months after randomization
Measured: 6 months after randomization
mRS score 6 months after randomization
mRS score 6 months after randomization
Measured: 6 months after randomization
Changes in fundus blood vessels and fundus structures 6 months after randomization (average thickness of retinal nerve fiber layer around optic disc and average thickness of macular ganglion cell complex/ganglion cell-inner plexus layer
Changes in fundus blood vessels and fundus structures 6 months after randomization (average thickness of retinal nerve fiber layer around optic disc and average thickness of macular ganglion cell complex/ganglion cell-inner plexus layer
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-acute Carotid Artery OcclusionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dapeng Mo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dapeng Mo, Beijing Tiantan Hospital
- Investigators
- Dapeng Mo, MD, Principal investigator, Beijing Tiantan Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803419
- Sponsor's protocol ID
- HX-A-2026054
- Acronym
- ASCENT
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment for Symptomatic Non-acute Carotid Occlusion - A Multicenter, Prospective, Blind Endpoint, Pilot， Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07803419
- Acronym / sponsor ID
- ASCENT / HX-A-2026054
- Keywords
- Non-acute Carotid Artery Occlusion, Chronic Carotid Artery Occlusion, Symptomatic Carotid Artery Occlusion, Endovascular Recanalization, Balloon Guide Catheter, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dapeng MoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 3 Sep 2026 (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.
This study is a multicenter, prospective, randomized, open-label, blinded-endpoint clinical trial designed to evaluate the safety and potential efficacy of endovascular recanalization strategies in patients with symptomatic non-acute carotid artery occlusion and cognitive impairment. Eligible participants will be randomly assigned to best medical treatment alone, endovascular recanalization without proximal protection plus best medical treatment, or endovascular recanalization with proximal balloon protection plus best medical treatment. The study will assess whether endovascular recanalization improves cognitive function and whether proximal protection reduces procedure-related new ischemic lesions on diffusion-weighted magnetic resonance imaging.
Detailed description
Symptomatic non-acute carotid artery occlusion may lead to recurrent ischemic events, chronic cerebral hypoperfusion, and cognitive decline. Best medical treatment is the standard foundation of care, but selected patients with persistent hypoperfusion may remain at risk. Endovascular recanalization may improve cerebral perfusion, but procedure-related distal embolization and new ischemic lesions remain important safety concerns.
Eligible patients will have symptomatic non-acute carotid artery occlusion, ipsilateral cerebral hypoperfusion, and baseline cognitive impairment defined by an education-adjusted Montreal Cognitive Assessment score of 25 or lower. Participants will be randomized in a 1:1:1 ratio to best medical treatment alone, endovascular recanalization without proximal protection plus best medical treatment, or endovascular recanalization with proximal balloon protection plus best medical treatment.
In the proximal protection group, a balloon guide catheter will be used to achieve proximal flow arrest or flow control during key procedural steps. In the unprotected endovascular group, recanalization will be performed without routine proximal balloon flow control. The primary safety outcome is the number of new ischemic lesions on diffusion-weighted magnetic resonance imaging within 24 to 72 hours. The primary efficacy outcome is the change in Montreal Cognitive Assessment score from baseline to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Best Medical Treatment | Active comparator | Other: Guideline-Based Best Medical TreatmentParticipants in this arm will receive guideline-based best medical treatment, including antiplatelet therapy and management of vascular risk factors. |
| Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical Treatment | Experimental | Procedure: Endovascular Recanalization With Proximal Balloon ProtectionParticipants in this arm will undergo endovascular recanalization with proximal balloon protection in addition to guideline-based best medical treatment. Proximal balloon protection will be used to achieve temporary proximal flow arrest or flow control during key procedural steps. |
| Endovascular Recanalization Without Proximal Protection Plus Best Medical Treatment | Experimental | Procedure: Endovascular Recanalization Without Proximal ProtectionParticipants in this arm will undergo endovascular recanalization without routine proximal balloon flow control, in addition to guideline-based best medical treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The age ranged from 18 to 80 years
- Unilateral carotid artery occlusion confirmed by CTA or DSA (excluding anterior and middle cerebral artery occlusion)
- Complete 3T-MRI within 1-3 days before operation
- The time of carotid artery occlusion was more than 24h (confirmed by imaging or according to the patient's condition), and not more than 3 months
- Ischemic stroke or TIA related to occluded vessels existed in the past 3 months, and the last ischemic event was > 2 weeks; and there was cognitive impairment, MoCA score ≤ 25 after education correction
Key exclusion criteria (20 listed)
- There was severe neurological dysfunction (mRS ≥ 4) before enrollment
- The ipsilateral common carotid artery was occluded, or the ipsilateral middle cerebral artery was severely stenosed or occluded
- Non atherosclerotic occlusion (such as vasculitis, moyamoya disease, etc.)
- Patients with massive cerebral infarction (infarction volume based on MRI-DWI/ADC is more than 70ml)
- Untreated intracranial aneurysms, intracranial tumors (except meningiomas) or any intracranial vascular malformations
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 |
|---|---|---|
| Guideline-Based Best Medical TreatmentGuideline-based best medical treatment includes antiplatelet therapy and management of vascular risk factors, such as blood pressure, lipid, glucose, and lifestyle management, according to current clinical practice. | Other | Best Medical Treatment |
| Endovascular Recanalization With Proximal Balloon ProtectionEndovascular recanalization will be performed using neurointerventional techniques. A balloon guide catheter will be positioned proximally to achieve temporary flow arrest or flow control during key lesion-treatment steps, with the aim of reducing distal migration of thrombus or plaque debris. | Procedure or surgery | Endovascular Recanalization With Proximal Balloon Protection Plus Best Medical Treatment |
| Endovascular Recanalization Without Proximal ProtectionEndovascular recanalization will be performed using standard neurointerventional techniques without routine proximal balloon flow arrest or flow control. | Procedure or surgery | Endovascular Recanalization Without Proximal Protection Plus Best Medical Treatment |
Primary outcome
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization
Time frame: 6 months after randomization
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization
Total number of new infarcts on DWI-MRI within 24-72 hours after randomization
Time frame: Within 24-72h after randomization
Total number of new infarcts on DWI-MRI within 24-72 hours after randomization
15 secondary outcomes
The volume of new infarcts 24-72 hours after randomization
Time frame: 24-72 hours after randomization
Incidence of new infarcts 24-72 hours after randomization
Time frame: 24-72 hours after randomization
Distribution characteristics of new infarcts 24-72 hours after randomization (within or beyond the scope of responsible vessels)
Time frame: 24-72 hours after randomization
location of new infarcts 24-72 hours after randomization (only cortical area, only deep white matter area, cortex and white matter were involved)
Time frame: 24-72 hours after randomization
The average number of new infarcts per enrolled patient 24-72 hours after randomization
Time frame: 24-72 hours after randomization
The average number of new infarcts in the responsible vessels of each enrolled patient 24-72 hours after randomization
Time frame: 24-72 hours after randomization
The average number of new infarcts beyond the scope of responsible vessels per enrolled patient 24-72 hours after randomization
Time frame: 24-72 hours after randomization
The rate of symptomatic intracranial hemorrhage (SICH) within 72 hours after randomization (Heidelberg bleeding classification)
Time frame: Within 72 hours after randomization
Operation related complications within 72 hours after randomization (operation related complications, defined as arterial dissection, new area embolism, cavernous sinus fistula, arterial perforation, subarachnoid hemorrhage, etc.)
Time frame: Within 72 hours after randomization
Any stroke (hemorrhagic or ischemic) or death within 30 days after randomization
Time frame: Within 30 days after randomization
Occurrence of recurrent ischemic stroke (symptomatic ischemic cerebral infarction or TIA) of responsible vessels within 6 months after randomization
Time frame: Within 6 months after randomization
Restenosis or re-occlusion of target vessels confirmed by CTA/DSA 6 months after randomization
Time frame: 6 months after randomization
The changes of cognitive function (MMSE score) compared with baseline 6 months after randomization
Time frame: 6 months after randomization
mRS score 6 months after randomization
Time frame: 6 months after randomization
Changes in fundus blood vessels and fundus structures 6 months after randomization (average thickness of retinal nerve fiber layer around optic disc and average thickness of macular ganglion cell complex/ganglion cell-inner plexus layer
Time frame: 6 months after randomization
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 3 Sep 2026.
- 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.
Dapeng Mo, MD principal investigator
Beijing Tiantan Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guideline-Based Best Medical Treatment, Endovascular Recanalization With Proximal Balloon Protection and Endovascular Recanalization Without Proximal Protection in people with Non-acute Carotid Artery Occlusion and Cognitive Impairment, run by Dapeng Mo 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 10 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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 Dapeng Mo, MD (18811039300, bjttmodp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of cognitive function (MoCA score) compared with baseline 6 months after randomization (time frame: 6 months after randomization). 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?
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 3 Sep 2026.