Stroke, IschemicPhase 3RESILIENTExtNCT04256096
Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window
A Phase 3 study testing Thrombectomy in people with Stroke, Ischemic, run by Hospital de Clinicas de Porto Alegre at 14 sites in Brazil.
Trial summary
A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 14 sitesBrazil
- Study dates
- 9 Mar 2020to 1 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
- No significant pre-stroke functional disability (mRS ≤2)
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging)
- Age ≥18 years (no upper age limit)
- Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
- The presence of Age-Adjusted modified Clinical ASPECTS Mismatch (mCAM) defined as ASPECTS 5-10 and one of the following criteria:
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- NIHSS ≥ 8 and >50% involvement in 0-1 Cortical (e.g. M1-6) ASPECTS areas (any age);
- NIHSS ≥ 8 and >50% involvement in 0-2 Cortical (e.g. M1-6) ASPECTS areas (and age < 80 years old);
- NIHSS ≥ 15 and >50% involvement in 0-3 Cortical (e.g. M1-6) ASPECTS areas (and age < 80 years old).
- Patient treatable within 6-24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as arterial puncture.
- Informed consent obtained from patient or acceptable patient surrogate
Who cannot join
- -Clinical criteria
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 30.000/µL
- Baseline blood glucose of < 50mg/dL
- Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
- Patients in coma defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
Show all 24Show fewer
- Seizures at stroke onset which would preclude obtaining a baseline NIHSS
- Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
- History of life-threatening allergy (more than rash) to contrast medium
- Subjects who has received IV t-PA treatment beyond 4.5 hours from the beginning of the symptoms
- Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Cerebral vasculitis
- Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
- Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
- Neuroimaging criteria
- Hypodensity on CT or restricted diffusion on MRI amounting to an ASPECTS score of <5.
- Complete involvement of more than 3 cortical ASPECTS areas (e.g. M1, M2, M3, M4, M5, or M6).
- Complete absence of leptomeningeal collaterals on CT angiography (e.g. Malignant CTA pattern or score 0).
- CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).
- Significant mass effect with midline shift.
- Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
- Evidence of intracranial tumor (except small meningioma).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Brazil14 sites, 14 recruiting
- Not yet recruiting
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo
Rodrigo Bazan, PhD, 14981157727, bazan.r@terra.com.br
- Recruiting
Hospital de Base
Brasília, Federal District
Leticia C Rebello, MD, 61999150626, letirebello@gmail.com
- Not yet recruiting
Hospital de Clínicas - UNICAMP
Campinas, São Paulo
Fabricio B Cardoso, MD, 019981254952, fabriciobuchdid@hotmail.com
- Not yet recruiting
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná
Viviane F Zetola, 0154199761660, viviane.zetola@gmail.com
- Recruiting
Hospital Geral de Fortaleza
Fortaleza, Ceará
Fabricio Lima, PhD, 85999982150, fabricio.lima.neuro@gmail.com
- Not yet recruiting
Conferencia Sao jose do Avai
Itaperuna, Rio de Janeiro
Ivete itaperuna P Goncalves, 22988315201, ipilloster@gmail.com
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035007
Natacha Fleck, 51992699829, pesquisaneurovascular@gmail.com
Ana Julia Lehnen, 51992870762, anajlehnen@gmail.com
- Not yet recruiting
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul
Alexandre Maulaz, 51992826915, maulaz@terra.com.br
- Recruiting
Hospital das Clinicas de Ribeirao Preto
Ribeirão Preto, São Paulo
Octavio M Pontes-Neto, PhD, 16981013465, ompneto@gmail.com
- Not yet recruiting
Fundacao Faculdade Regional de Medicina S J Rio Preto
São José do Rio Preto, São Paulo
Raquel Hidalgo, MD, 17997640004, draquelhidalgo@gmail.com
- Not yet recruiting
Instituto de Assistência Médica ao Servidor Público Estadual de Sao Paulo
São Paulo, São Paulo
André Rezende, MD, +5511981359842, andrerezende@neurointervencao.com.br
- Not yet recruiting
Universidade Federal de São Paulo - UNIFESP/EPM
São Paulo, São Paulo
Gisele S Silva, PhD, giselesampaio@hotmail.com
- Recruiting
Hospital das Clínicas de Uberlândia
Uberlândia, Minas Gerais
Jullyanna Shinosaki, MD, +553491161478, jsm_shinosaki@yahoo.com.br
- Recruiting
Associacao Congregacao de Santa Catarina
Vitória, Espírito Santo, 29050-335
Jose A Fiorot Jr, PhD, 27992778579, fiorotjr@gmail.com
About this study
Official title: Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial in the Extended Time Window
A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well
Read the detailed description
Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterior circulation ischemic stroke between 8 and 24 hours from time last seen well. Randomization will be done under a minimization process using age (≤68 vs. >68 years), baseline NIHSS (<17 v. ≥17), ASPECTS (5-7 vs. 8-10), therapeutic window (6-12 or 12-24 hours after TLKW), occlusion site (Intracranial ICA or M1), and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators.
- Conditions
- Stroke, Ischemic
- Being tested
- Thrombectomy
- Keywords
- stroke, ischemic stroke, thrombectomy, treatment, acute stroke
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrombectomyDevice
Also called Endovascular treatment
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
| Study group | Role | What they receive |
|---|---|---|
| thrombectomy | Experimental | mechanical thrombectomy with stent-retriever and/or thromboaspiration Receives: Device: Thrombectomy |
| Clinical treatment | Active comparator | Best Medical treatment Receives: Device: Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale scores
Distribution of the modified Rankin Scale scores at 90 days (shift analysis). The score range from zero to 6 with higher values indicating a worst functional outcome at 90 days
Measured: 90 days
Secondary outcomes (6)
Proportion of Patients with Functional independence in 90 days
Functional independence defined as mRS ≤2
Measured: 90 days
Disability on the utility-weighted modified Rankin scale (UW-mRS)
Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS). The score range from 1 to zero with higher values indicating a better functional outcome at 90 days
Measured: 90 days
Quality of life measured by EuroQol Group 5-Dimension Self-Report Questionnaire (EuroQol / EQ5D)
Quality of life analysis as measured by EuroQol/EQ5D 5-Dimension Self-Report Questionnaire, on which scores range from -0.176 to 1, with higher values indicating a better quality of life]) at 90 days
Measured: 90 days and 1 year
Mortality at 90 days
Mortality at 90 days
Measured: 90 days
Proportion of patients with Intracranial Hemorrhage at 24 hours
Clinically significant ICH rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans.
Measured: 24 hours
Procedural related complications
Procedural related complications: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start9 Mar 2020
- Primary completion1 Feb 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto, Hospital Geral de Fortaleza, Hospital de Base, Federal University of São Paulo, Fundação Faculdade Regional de Medicina de São José do Rio Preto, UPECLIN HC FM Botucatu Unesp, University of Campinas, Brazil, Irmandade Santa Casa de Misericórdia de Porto Alegre, Universidade Federal do Paraná, Hospital Estadual Central, Hospital Sao Jose do Avai, Irmandade da Santa Casa de Misericordia de Sao Paulo, Federal University of Uberlandia, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Responsible party
- Principal investigator, SHEILA CRISTINA OURIQUES MARTINS, Hospital de Clinicas de Porto Alegre
- Investigators
- Raul G Nogueira, MD, Principal investigator, Emory UniversitySheila CO Martins, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256096
- Sponsor's protocol ID
- 17877519.6.1001.5327
- Acronym
- RESILIENTExt
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the principal investigators
Publications
Martins SO, Sampaio Silva G, Montalverne FJ, Rebello LC, Lima FO, Wagner M, Abud DG, Carbonera LA, de Souza AC, Filho JO, Bezerra DC, Pontes-Neto OM, Nogueira R. Randomization of Endovascular Treatment with Stent-Retriever and/or Thromboaspiration versus Best Medical Therapy in Acute Ischemic Stroke Due to Large Vessel Occlusion in the Extended Time Window Trial (RESILIENT-Extend): Rationale and Design. Int J Stroke. 2026 Jul 17:17474930261472689. doi: 10.1177/17474930261472689. Online ahead of print.
PubMed 42466577Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD010995. doi: 10.1002/14651858.CD010995.pub3.
PubMed 34850380
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial in the Extended Time Window
- ClinicalTrials.gov ID
- NCT04256096
- Acronym / sponsor ID
- RESILIENTExt / 17877519.6.1001.5327
- Conditions
- Stroke, Ischemic
- Keywords
- stroke, ischemic stroke, thrombectomy, treatment, acute stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Hospital das Clínicas de Ribeirão Preto, Hospital Geral de Fortaleza, Hospital de Base, Federal University of São Paulo, Fundação Faculdade Regional de Medicina de São José do Rio Preto, UPECLIN HC FM Botucatu Unesp, University of Campinas, Brazil, Irmandade Santa Casa de Misericórdia de Porto Alegre, Universidade Federal do Paraná, Hospital Estadual Central, Hospital Sao Jose do Avai, Irmandade da Santa Casa de Misericordia de Sao Paulo, Federal University of Uberlandia, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 1 Feb 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 5 Feb 2020 (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.
A phase III, randomized, multi-center, open label clinical trial that will examine whether endovascular treatment is superior to standard medical therapy alone in patients who suffer a large vessel anterior circulation ischemic stroke within 8-24 hours from time last seen well
Detailed description
Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterior circulation ischemic stroke between 8 and 24 hours from time last seen well. Randomization will be done under a minimization process using age (≤68 vs. >68 years), baseline NIHSS (<17 v. ≥17), ASPECTS (5-7 vs. 8-10), therapeutic window (6-12 or 12-24 hours after TLKW), occlusion site (Intracranial ICA or M1), and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone
| Arm | Type | Receives |
|---|---|---|
| thrombectomy | Experimental | Device: Thrombectomymechanical thrombectomy with stent-retriever and/or thromboaspiration |
| Clinical treatment | Active comparator | Device: ThrombectomyBest Medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
- No significant pre-stroke functional disability (mRS ≤2)
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging)
- Age ≥18 years (no upper age limit)
- Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
Key exclusion criteria (24 listed)
- -Clinical criteria
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 30.000/µL
- Baseline blood glucose of < 50mg/dL
- Severe, sustained hypertension (SBP > 185 mm Hg or DBP > 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
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 |
|---|---|---|
| ThrombectomyAlso: Endovascular treatmentEndovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice) | Device | Clinical treatment, thrombectomy |
Primary outcome
Modified Rankin Scale scores
Time frame: 90 days
Distribution of the modified Rankin Scale scores at 90 days (shift analysis). The score range from zero to 6 with higher values indicating a worst functional outcome at 90 days
6 secondary outcomes
Proportion of Patients with Functional independence in 90 days
Time frame: 90 days
Disability on the utility-weighted modified Rankin scale (UW-mRS)
Time frame: 90 days
Quality of life measured by EuroQol Group 5-Dimension Self-Report Questionnaire (EuroQol / EQ5D)
Time frame: 90 days and 1 year
Mortality at 90 days
Time frame: 90 days
Proportion of patients with Intracranial Hemorrhage at 24 hours
Time frame: 24 hours
Procedural related complications
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Derived from this study: PubMed 42466577Martins SO, Sampaio Silva G, Montalverne FJ, Rebello LC, Lima FO, Wagner M, Abud DG, Carbonera LA, de Souza AC, Filho JO, Bezerra DC, Pontes-Neto OM, Nogueira R. Randomization of Endovascular Treatment with Stent-Retriever and/or Thromboaspiration versus Best Medical Therapy in Acute Ischemic Stroke Due to Large Vessel Occlusion in the Extended Time Window Trial (RESILIENT-Extend): Rationale and Design. Int J Stroke. 2026 Jul 17:17474930261472689. doi: 10.1177/17474930261472689. Online ahead of print.
- Derived from this study: PubMed 34850380Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD010995. doi: 10.1002/14651858.CD010995.pub3.
- Individual participant dataSharing planned: Yes. Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the principal investigators
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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.
Raul G Nogueira, MD principal investigator
Emory University
Sheila CO Martins, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thrombectomy in people with Stroke, Ischemic, run by Hospital de Clinicas de Porto Alegre at 14 sites in Brazil.
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 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Brazil. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheila CO Martins, MD, PhD (51999628467, scmartins@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale scores (time frame: 90 days). 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 NCT04256096, which also lists 2 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 10 Feb 2021.