AMI Cardiogenic ShockOASIS-AMICSNCT06964685
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
An observational study of AMI Cardiogenic Shock, run by Abiomed Inc. at 18 sites in United States.
Trial summary
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AMI Cardiogenic Shock
- What is being tested?
- Impella
- Type of treatment
- Medical device
- How many people
- 350 participants
- Where
- 18 sitesUnited States
- Study dates
- 10 Jul 2025to 30 Oct 2028
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.
Who may be able to join
- Acute myocardial infarction (AMI) of <36 hours duration from symptom onset to cath lab arrival, confirmed by:
- ECG and/or biomarker evidence of ST-segment elevation myocardial infarction (STEMI), STEMI equivalents, or new or presumed new left bundle branch block or
- ECG and/or biomarker evidence of non-ST-segment elevation myocardial infarction (NSTEMI) and angiographic evidence of one or more culprit vessels
- Cardiogenic shock confirmed by at least two of the following:
- Tissue hypoperfusion, manifested by an arterial or venous blood lactate level ≥2.5 mmol/L or SvO2 <55% in the presence of a PaO2 > 90mmHg
- Systolic blood pressure <100 mmHg or need for vasoactive agents to maintain systolic blood pressure ≥100 mmHg
Show all 13Show fewer
- Hemodynamic criteria represented by a cardiac index of <2.2 L/min/m^2 or a cardiac power output ≤0.6 W
- Cardiogenic shock that develops under one of the following conditions:
- prior to primary PCI, with <24 hours from the onset of shock to cath lab arrival, or
- <12 hours after initiating primary PCI
- Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
- Age ≥18 years
- Europe only: Subject or legally designated representative (LDR) or Independent Physician has provided written informed consent for participation in the observational study
Who cannot join
- Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure).
- Shock principally due to a cause other than LV failure, including:
- RV infarction, hypovolemia, anaphylaxis, hemorrhage, sepsis, myocarditis, pulmonary embolism, pneumothorax, or high cardiac output shock
- Severe arrhythmias as the primary cause of low cardiac output, including acute bradyarrhythmias, tachyarrhythmias, or advanced heart block
- Known mechanical complications of AMI that may cause cardiogenic shock such as free wall rupture, ventricular septal defect or papillary muscle rupture with acute mitral regurgitation
- Procedural complication of the PCI that results in coronary perforation
Show all 16Show fewer
- Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility
- Acute or chronic aortic dissection
- Prior PCI at another institution for the present infarction
- Thrombolytic therapy for the present infarction
- Not obeying verbal commands after preadmission or in-hospital cardiac arrest, indicative of possible anoxic brain injury NOTE:
- Non-intubated subjects: A positive and appropriate response to commands must be repeatable on at least two (2) instances to rule out reflex response to voice
- Intubated subjects are excluded if: They were not following verbal commands immediately prior to intubation, or They were not clearly following verbal commands after intubation within 6 hours post-PCI
- Infective endocarditis
- Other severe, concomitant disease with limited life expectancy <1 year (other than cardiogenic shock)
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached the timing of its primary endpoint
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
United States18 sites, 18 recruiting
- Recruiting
New Mexico Heart
Albuquerque, New Mexico, 87102
Mark Bieniarz, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Ajar Kochar
- Recruiting
Bethesda North Hospital
Cincinnati, Ohio, 45242
- Recruiting
Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
- Recruiting
Inova Fairfax
Falls Church, Virginia, 22042
Behnam Tehrani
- Recruiting
Straub Benioff Medical Center
Honolulu, Hawaii, 96813
Rayji Tsutsui
- Recruiting
UTHealth Memorial Hermann
Houston, Texas, 77030
Sukhdeep Basra
- Recruiting
Cardiology Associates Research Group (St. Bernard's Hospital)
Jonesboro, Arkansas, 72401
- Recruiting
Parkwest Medical Center
Knoxville, Tennessee, 37923
- Recruiting
NCH Rooney Heart Institute
Naples, Florida, 34102
- Recruiting
St. Joseph Hospital Orange
Orange, California, 92868
Brian Kolski, MD
- Recruiting
OSF Saint Francis
Peoria, Illinois, 61637
Marco Barzallo
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
- Recruiting
Legacy Emanuel Medical Center
Portland, Oregon, 97227
Amish Desai
- Recruiting
Methodist Hospital
San Antonio, Texas, 78229
- Recruiting
Torrance Memorial Medical Center
Torrance, California, 90505
- Recruiting
Saint Francis Hospital
Tulsa, Oklahoma, 74136
About this study
Official title: Observational Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 <55% with a normal PaO2) and systolic blood pressure <100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.
- Conditions
- AMI Cardiogenic Shock
- Being tested
- Impella
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpellaDevice
US commercially approved Impella CP is the device that study inclusion will be based on. Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety
Composite safety endpoint (major bleeding, acute limb ischemia, or acute kidney injury requiring renal replacement therapy)
Measured: All in-hospital events through discharge, an average of 15 days
Secondary outcomes (14)
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Measured: Up to 1 year post-Impella implant
All-cause mortality
Measured: Up to 1 year post-Impella implant
Cardiovascular death
Measured: Up to 1 year post-Impella implant
Cardiovascular hospitalizations
Measured: Up to 1 year post-Impella implant
Heart failure hospitalizations
Measured: Up to 1 year post-Impella implant
Heart transplant or durable LVAD implantation
Measured: Up to 1 year post-Impella implant
Any new renal replacement therapy (RRT)
Measured: Up to 1 year post-Impella implant
Acute kidney injury (AKI)
Measured: In-hospital through discharge, up to 15 days
Major bleeding
Measured: In-hospital through discharge, up to 15 days
Hemolysis
Measured: In-hospital through discharge, up to 15 days
Acute limb ischemia (ALI)
Measured: In-hospital through discharge, up to 15 days
Major vascular complications
Measured: In-hospital through discharge, up to 15 days
Stroke
Measured: In-hospital through discharge, up to 15 days
Worsening Aortic Regurgitation
Measured: In-hospital through discharge, up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start10 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AMI Cardiogenic ShockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964685
- Sponsor's protocol ID
- ABMD-CIP-2024-04
- Acronym
- OASIS-AMICS
- Status last verified
- Jul 2026
- First submitted
- 7 Apr 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049.
PubMed 35835491Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.
PubMed 38743805Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
PubMed 9308598Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW; Society for Cardiovascular Angiography and Interventions. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). Catheter Cardiovasc Interv. 2014 Jan 1;83(1):27-36. doi: 10.1002/ccd.25135. Epub 2013 Oct 16.
PubMed 23894025Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
PubMed 30571511
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT06964685
- Acronym / sponsor ID
- OASIS-AMICS / ABMD-CIP-2024-04
- Conditions
- AMI Cardiogenic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 9 May 2025 (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 observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 <55% with a normal PaO2) and systolic blood pressure <100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study.
Key inclusion criteria (13 listed)
- Acute myocardial infarction (AMI) of <36 hours duration from symptom onset to cath lab arrival, confirmed by:
- Cardiogenic shock confirmed by at least two of the following:
- Cardiogenic shock that develops under one of the following conditions:
- Patient was supported with Impella CP as the initial MCS device for cardiogenic shock
- Age ≥18 years
Key exclusion criteria (16 listed)
- Any contraindication listed in the Impella CP IFU if known to be present (i.e. mural thrombus in the left ventricle; presence of a mechanical aortic valve or heart constrictive device; aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); severe arterial disease precluding placement of the Impella system; presence of an atrial or ventricular septal defect (including post-infarct VSD); significant right heart failure; left ventricular rupture; cardiac tamponade; combined cardiorespiratory failure).
- Shock principally due to a cause other than LV failure, including:
- Other mechanical circulatory support already in place for present indication, including intra-aortic balloon counter-pulsation or patients with Impella CP placement prior to transfer to the cath lab at the tertiary facility
- Acute or chronic aortic dissection
- Prior PCI at another institution for the present infarction
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 |
|---|---|---|
| ImpellaUS commercially approved Impella CP is the device that study inclusion will be based on. Only patients with AMICS who receive Impella CP as the first Impella device after cardiogenic shock onset will be included in the study. | Device | – |
Primary outcome
Composite Safety
Time frame: All in-hospital events through discharge, an average of 15 days
Composite safety endpoint (major bleeding, acute limb ischemia, or acute kidney injury requiring renal replacement therapy)
14 secondary outcomes
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: Up to 1 year post-Impella implant
All-cause mortality
Time frame: Up to 1 year post-Impella implant
Cardiovascular death
Time frame: Up to 1 year post-Impella implant
Cardiovascular hospitalizations
Time frame: Up to 1 year post-Impella implant
Heart failure hospitalizations
Time frame: Up to 1 year post-Impella implant
Heart transplant or durable LVAD implantation
Time frame: Up to 1 year post-Impella implant
Any new renal replacement therapy (RRT)
Time frame: Up to 1 year post-Impella implant
Acute kidney injury (AKI)
Time frame: In-hospital through discharge, up to 15 days
Major bleeding
Time frame: In-hospital through discharge, up to 15 days
Hemolysis
Time frame: In-hospital through discharge, up to 15 days
Acute limb ischemia (ALI)
Time frame: In-hospital through discharge, up to 15 days
Major vascular complications
Time frame: In-hospital through discharge, up to 15 days
Stroke
Time frame: In-hospital through discharge, up to 15 days
Worsening Aortic Regurgitation
Time frame: In-hospital through discharge, up to 15 days
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 6 Jul 2026.
- Background: PubMed 35835491Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049.
- Background: PubMed 38743805Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.
- Background: PubMed 9308598Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, Jones DN. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997 Sep;26(3):517-38. doi: 10.1016/s0741-5214(97)70045-4.
- Background: PubMed 23894025Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW; Society for Cardiovascular Angiography and Interventions. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). Catheter Cardiovasc Interv. 2014 Jan 1;83(1):27-36. doi: 10.1002/ccd.25135. Epub 2013 Oct 16.
- Background: PubMed 30571511Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Circulation. 2018 Nov 13;138(20):e618-e651. doi: 10.1161/CIR.0000000000000617. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMI Cardiogenic Shock, run by Abiomed Inc. at 18 sites in United States.
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 13 inclusion and 16 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. 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 Sameera Dasari, PhD (978-914-8882, sdasar12@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Safety (time frame: All in-hospital events through discharge, an average of 15 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 NCT06964685, which also lists 5 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 6 Jul 2026.