Carotid Artery DiseasesNCT04792255
Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting
A study testing Carotid artery stenting with standard contrast media protocol, Carotid artery stenting with reduced contrast media protocol and Carotid Duplex Ultrasound in people with Carotid Artery Diseases, run by Kinepict Health Ltd. at 1 site in Hungary.
Trial summary
Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2). Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Carotid artery stenting with standard contrast media protocol, Carotid artery stenting with reduced contrast media protocol and Carotid Duplex Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHungary
- Study dates
- 1 Jun 2022to 31 Dec 2023
- Phase
- Interventional
- 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
- Age > 18 y
- Carotid stenosis defined as:
- Stenosis ≥70% by computer tomography angiography (NASCET criteria); OR by duplex-ultrasound with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s
- Carotid stenosis is treatable with CAS
Who cannot join
- History of stroke or TIA ipsilateral to the stenosis within 30 days of randomization
- Acute myocardial infarction
- Severe chronic kidney disease: GFR>30ml/min/m2
- Severe heart failure: NYHA IV
- Severe liver failure: Child-Pugh 3
- Iodine contrast allergy
- Coagulopathy
- Hematological bleeding disorders
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Heart and Vascular Center
Budapest, 1122
Péter Sótonyi, Prof,MD,PhD
Balázs Nemes, MD,PhD
About this study
Official title: Investigation of Dose Management Capabilities of Digital Variance Angiography: Contrast Media Dose Reduction in Patients Undergoing Carotid Artery Stenting - a Prospective Randomized Clinical Trial
Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2).
Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the image quality (3).
Read more
CAS is an alternative treatment option for carotid artery revascularization in selected patient groups. Similar to most of the minimally invasive endovascular interventions, CAS also carries the risk of contrast-induced acute kidney injury, which is considered to be an independent predictor of 30-day major adverse events (4).
The aim of this study is to apply DVA in patients undergoing carotid artery stenting (CAS) and utilize this technique to reduce contrast dose during the interventions, without affecting the intraprocedural radiation dose and the clinical outcome of the procedures. Investigators believe that the reduction in contrast media use and the associated image quality with the technique of DVA imaging can be incorporated into the everyday clinical practice, and will play an important role in improving the rate of contrast-induced acute kidney injury.
- Conditions
- Carotid Artery Diseases
- Being tested
- Carotid artery stenting with standard contrast media protocol, Carotid artery stenting with reduced contrast media protocol, Carotid Duplex Ultrasound
- Keywords
- Radiocontrast media reduction, X-ray angiography, Digital Variance Angiography, Digital Subtraction Angiography, carotid artery stenting, Kinepict
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid artery stenting with standard contrast media protocolProcedure or surgery
Also called Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiography
Radial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool.
Carotid artery stenting with reduced contrast media protocolProcedure or surgery
Also called Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiography
Radial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool.
Carotid Duplex UltrasoundDiagnostic test
Pre- and postinterventional assessment of the treated internal carotid artery.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Reduced contrast media dose group | Experimental | Reduced contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol).
Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml of 50% contrast media (3 ml iodined contrast media, 3 ml physiologic saline) with a 3 ml/s flow rate.
DSA and DVA images will be calculated; DVA images will be used for diagnosis and interventions. Receives: Procedure: Carotid artery stenting with reduced contrast media protocol; Diagnostic Test: Carotid Duplex Ultrasound |
| Group B: Standard contrast media dose group | Active comparator | Standard contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol).
Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml iodined contrast media with a 3 ml/s flow rate.
DSA and DVA images will be calculated; DSA images will be used for diagnosis and interventions. Receives: Procedure: Carotid artery stenting with standard contrast media protocol; Diagnostic Test: Carotid Duplex Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSA-related contrast media use
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Measured: During the procedure
Total procedural contrast media use
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Measured: During the procedure
Image quality, graded by independent observers
Observations based on a 5-level Likert scale (1-poor image quality, 3-medium image quality, 5-outstanding image quality)
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Total procedural dose area product
Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)
Measured: During the procedure
DSA-related dose area product
Indicator of a patient's irradiation dosage (microGy*cm2 or Gy*cm2)
Measured: During the procedure
Total procedural time
Duration of the whole procedure, from arterial access till the removal of every tool (min)
Measured: During the procedure
Number of protocol changes during DVA usage
Number of occasions when the reduced contrast media protocol has to be switched back to conventional protocol because of the unsuitable image quality
Measured: During the procedure
Residual stenosis
The difference between the normal reference segment diameter and the minimum lumen diameter of the treated lesion after CAS (%)
Measured: During the procedure
Focal neurological symptoms
Focal neurological symptoms ipsilateral to the treated carotid artery during the postprocedural observation period
Measured: During the procedure and up to 1 day
Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound
Peak-systolic and end-diastolic velocities (cm/sec)
Measured: Preoperatively and 1 day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jun 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled participants will undergo carotid artery stenting with different image acquisition protocol of the pre-and postinterventional angiographies from anteroposterior and lateral views, and intraoperative angiographies with C-arm angulations based on the operator's decision. In the active comparator group, a standard contrast media dose and DSA images will be used for diagnosis whereas in the experimental group a reduced contrast media dose will be applied (50% decrease compared to the standard DSA protocol) and the operator will use DVA images for the diagnosis.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kinepict Health Ltd.
- Sponsor type
- Research network
- Collaborators
- Semmelweis University, Bács-Kiskun County Teaching Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792255
- Sponsor's protocol ID
- Kinepict-009
- Status last verified
- Jul 2022
- First submitted
- 23 Feb 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gyano M, Gog I, Orias VI, Ruzsa Z, Nemes B, Csobay-Novak C, Olah Z, Nagy Z, Merkely B, Szigeti K, Osvath S, Sotonyi P. Kinetic Imaging in Lower Extremity Arteriography: Comparison to Digital Subtraction Angiography. Radiology. 2019 Jan;290(1):246-253. doi: 10.1148/radiol.2018172927. Epub 2018 Oct 16.
PubMed 30325284Orias VI, Gyano M, Gog I, Szollosi D, Veres DS, Nagy Z, Csobay-Novak C, Zoltan O, Kiss JP, Osvath S, Szigeti K, Zoltan R, Sotonyi P. Digital Variance Angiography as a Paradigm Shift in Carbon Dioxide Angiography. Invest Radiol. 2019 Jul;54(7):428-436. doi: 10.1097/RLI.0000000000000555.
PubMed 30829769Orias VI, Szollosi D, Gyano M, Veres DS, Nardai S, Csobay-Novak C, Nemes B, Kiss JP, Szigeti K, Osvath S, Sotonyi P, Ruzsa Z. Initial evidence of a 50% reduction of contrast media using digital variance angiography in endovascular carotid interventions. Eur J Radiol Open. 2020 Nov 17;7:100288. doi: 10.1016/j.ejro.2020.100288. eCollection 2020.
PubMed 33294499Paraskevas KI, Mikhailidis DP. Contrast-Induced Acute Kidney Injury in Patients Undergoing Carotid Artery Stenting: An Underestimated Issue. Angiology. 2017 Oct;68(9):752-756. doi: 10.1177/0003319716668934. Epub 2016 Sep 19.
PubMed 27645233
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Dose Management Capabilities of Digital Variance Angiography: Contrast Media Dose Reduction in Patients Undergoing Carotid Artery Stenting - a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04792255
- Acronym / sponsor ID
- Kinepict-009
- Conditions
- Carotid Artery Diseases
- Keywords
- Radiocontrast media reduction, X-ray angiography, Digital Variance Angiography, Digital Subtraction Angiography, carotid artery stenting, Kinepict
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kinepict Health Ltd.Research network
- Collaborators
- Semmelweis University, Bács-Kiskun County Teaching Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 Mar 2021 (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.
Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2).
Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to reduce contrast media use by 50% in carotid artery angiographic studies without affecting the image quality (3).
CAS is an alternative treatment option for carotid artery revascularization in selected patient groups. Similar to most of the minimally invasive endovascular interventions, CAS also carries the risk of contrast-induced acute kidney injury, which is considered to be an independent predictor of 30-day major adverse events (4).
The aim of this study is to apply DVA in patients undergoing carotid artery stenting (CAS) and utilize this technique to reduce contrast dose during the interventions, without affecting the intraprocedural radiation dose and the clinical outcome of the procedures. Investigators believe that the reduction in contrast media use and the associated image quality with the technique of DVA imaging can be incorporated into the everyday clinical practice, and will play an important role in improving the rate of contrast-induced acute kidney injury.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled participants will undergo carotid artery stenting with different image acquisition protocol of the pre-and postinterventional angiographies from anteroposterior and lateral views, and intraoperative angiographies with C-arm angulations based on the operator's decision. In the active comparator group, a standard contrast media dose and DSA images will be used for diagnosis whereas in the experimental group a reduced contrast media dose will be applied (50% decrease compared to the standard DSA protocol) and the operator will use DVA images for the diagnosis.
| Arm | Type | Receives |
|---|---|---|
| Group A: Reduced contrast media dose group | Experimental | Procedure: Carotid artery stenting with reduced contrast media protocol, Diagnostic Test: Carotid Duplex UltrasoundReduced contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol). Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml of 50% contrast media (3 ml iodined contrast media, 3 ml physiologic saline) with a 3 ml/s flow rate. DSA and DVA images will be calculated; DVA images will be used for diagnosis and interventions. |
| Group B: Standard contrast media dose group | Active comparator | Procedure: Carotid artery stenting with standard contrast media protocol, Diagnostic Test: Carotid Duplex UltrasoundStandard contrast media protocol: extracranial carotid artery intervention (2-4 fps according to the institutional protocol). Contrast administration with an automatic contrast injector: angiographic image acquisitions will be performed with 6 ml iodined contrast media with a 3 ml/s flow rate. DSA and DVA images will be calculated; DSA images will be used for diagnosis and interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 y
- Carotid stenosis defined as:
- Stenosis ≥70% by computer tomography angiography (NASCET criteria); OR by duplex-ultrasound with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s
- Carotid stenosis is treatable with CAS
Key exclusion criteria (8 listed)
- History of stroke or TIA ipsilateral to the stenosis within 30 days of randomization
- Acute myocardial infarction
- Severe chronic kidney disease: GFR>30ml/min/m2
- Severe heart failure: NYHA IV
- Severe liver failure: Child-Pugh 3
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 |
|---|---|---|
| Carotid artery stenting with standard contrast media protocolAlso: Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiographyRadial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool. | Procedure or surgery | Group B: Standard contrast media dose group |
| Carotid artery stenting with reduced contrast media protocolAlso: Arterial access, Preinterventional selective carotid artery angiography, Carotid artery stenting, Postinterventional selective carotid artery angiographyRadial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool. | Procedure or surgery | Group A: Reduced contrast media dose group |
| Carotid Duplex UltrasoundPre- and postinterventional assessment of the treated internal carotid artery. | Diagnostic test | Group A: Reduced contrast media dose group, Group B: Standard contrast media dose group |
Primary outcome
DSA-related contrast media use
Time frame: During the procedure
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Total procedural contrast media use
Time frame: During the procedure
Volume of the iodinated contrast agent used for enhancing the image quality (mL)
Image quality, graded by independent observers
Time frame: through study completion, an average of 1 year
Observations based on a 5-level Likert scale (1-poor image quality, 3-medium image quality, 5-outstanding image quality)
7 secondary outcomes
Total procedural dose area product
Time frame: During the procedure
DSA-related dose area product
Time frame: During the procedure
Total procedural time
Time frame: During the procedure
Number of protocol changes during DVA usage
Time frame: During the procedure
Residual stenosis
Time frame: During the procedure
Focal neurological symptoms
Time frame: During the procedure and up to 1 day
Preoperative and postoperative ipsilateral carotid artery flow by doppler ultrasound
Time frame: Preoperatively and 1 day after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 30325284Gyano M, Gog I, Orias VI, Ruzsa Z, Nemes B, Csobay-Novak C, Olah Z, Nagy Z, Merkely B, Szigeti K, Osvath S, Sotonyi P. Kinetic Imaging in Lower Extremity Arteriography: Comparison to Digital Subtraction Angiography. Radiology. 2019 Jan;290(1):246-253. doi: 10.1148/radiol.2018172927. Epub 2018 Oct 16.
- Background: PubMed 30829769Orias VI, Gyano M, Gog I, Szollosi D, Veres DS, Nagy Z, Csobay-Novak C, Zoltan O, Kiss JP, Osvath S, Szigeti K, Zoltan R, Sotonyi P. Digital Variance Angiography as a Paradigm Shift in Carbon Dioxide Angiography. Invest Radiol. 2019 Jul;54(7):428-436. doi: 10.1097/RLI.0000000000000555.
- Background: PubMed 33294499Orias VI, Szollosi D, Gyano M, Veres DS, Nardai S, Csobay-Novak C, Nemes B, Kiss JP, Szigeti K, Osvath S, Sotonyi P, Ruzsa Z. Initial evidence of a 50% reduction of contrast media using digital variance angiography in endovascular carotid interventions. Eur J Radiol Open. 2020 Nov 17;7:100288. doi: 10.1016/j.ejro.2020.100288. eCollection 2020.
- Background: PubMed 27645233Paraskevas KI, Mikhailidis DP. Contrast-Induced Acute Kidney Injury in Patients Undergoing Carotid Artery Stenting: An Underestimated Issue. Angiology. 2017 Oct;68(9):752-756. doi: 10.1177/0003319716668934. Epub 2016 Sep 19.
- Individual participant dataSharing planned: No
Related trials for Carotid Artery Diseases
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid artery stenting with standard contrast media protocol, Carotid artery stenting with reduced contrast media protocol and Carotid Duplex Ultrasound in people with Carotid Artery Diseases, run by Kinepict Health Ltd. at 1 site in Hungary.
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 4 inclusion and 8 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 9 Mar 2023. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Péter Sótonyi, MD, PhD (+36 20 825 8046, sotonyi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DSA-related contrast media use (time frame: During the procedure). The study lists 3 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 NCT04792255, which also lists 4 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 9 Mar 2023.