Critical Limb IschemiaPROMISENCT03970538

PROMISE II: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia

A study testing LimFlow System in people with Critical Limb Ischemia and Critical Lower Limb Ischemia, run by LimFlow, Inc. at 21 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The LimFlow System is intended for endovascular, minimally invasive procedures in patients who have a clinical diagnosis of chronic limb-threatening ischemia and who have been determined to have no surgical or endovascular treatment option (i.e., "no option"). Read more about this study

Who is it for?: Ages 18 to 95 years
Conditions the study is for: Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease
What is being tested?: LimFlow System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 21 sitesin 2 countries
Study dates: 6 Dec 2019to 28 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 95 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject must be ≥18 and ≤ 95 years of age
Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and
Rutherford Classification 5, ischemic ulceration or
Rutherford Classification 6, ischemic gangrene
Subject has been assessed by the principal investigator, reviewed by the Independent Review Committee (IRC), and determined that no conventional distal bypass surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.

Show all 18Show fewer

Prior stent(s) to the infrainguinal arteries (e.g. iliac, SFA, and popliteal) are allowed.
Planned minor amputation (e.g. partial toe, ray or proximal foot/transmetatarsal) of target extremity within 30 days after the index procedure is allowed.
Subject is willing and able to sign the informed consent form.
Subject is enrolled in an acceptable wound care network and has an adequate support network to ensure that subject is compliant with medication regimen and follow-up study visits.
Prior to enrollment (7-day window), women of childbearing potential must have a negative pregnancy test.
Primary wound is stable (e.g. not rapidly deteriorating and/or showing signs of healing)
Stable glycemic control, HbA1C < 10% (<269mg/dL)
Subjects requiring dialysis may be included, provided they meet all the following requirements:
On dialysis for > 6 months
Autologous arteriovenous (AV) fistula or peritoneal access used for hemodialysis
Serum albumin > 30 g/liter
BMI > 20

Who cannot join

Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the endovascular procedure: Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft or interventional revascularization procedure within 30 days.
Previous major amputation of the target limb or presence of a wound requiring a free flap or absence of adequate viable tissue.
Life expectancy less than 12 months.
Documented myocardial infarction or stroke within previous 90 days.

Show all 15Show fewer

Active infection (e.g. fever, significantly elevated WBC count >20.0 x 109/L, and/or positive blood culture) at the time of the index procedure that may preclude insertion of a prosthesis or require major amputation (e.g. osteomyelitis proximal to metatarsals).
Known or suspected allergies or contraindications to aspirin or P2Y12 inhibitors, heparin, stainless steel, nitinol or contrast agent that cannot be adequately pre-treated.
Subject is currently taking anti-coagulants, which in the opinion of the investigator, interferes with the subject's ability to participate in the study (i.e., intermittent interruption of therapy for procedure may compromise subject's safety).
Lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g. vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle).
Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in subjects not undergoing dialysis.
Severe heart failure (e.g. NYHA Class IV), which in the opinion of the investigator may compromise subject's ability to safely undergo a percutaneous procedure.
Any significant concurrent medical, psychological, or social condition, which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
15) Subject is unwilling, or unable, or unlikely for cognitive or social reasons to comply with any of the protocol or follow-up requirements.

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States20 sites

New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Seton Heart
Austin, Texas, 78723
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Atrium Health
Charlotte, North Carolina, 28203
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Prisma Health -- Midlands
Columbia, South Carolina, 29203
Unitypoint Health
Des Moines, Iowa, 50309
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
University of Florida
Gainesville, Florida, 32608
Prisma Health -- Upstate
Greenville, South Carolina, 29615
Baylor College of Medicine
Houston, Texas, 77030
Ochsner Health System
Kenner, Louisiana, 70065
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Saint Luke's Hospital
Lee's Summit, Missouri, 64086
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06519
University of California San Francisco
San Francisco, California, 94143
Harbor-UCLA Medical Center
Torrance, California, 90502
Coastal Carolina Surgical Associates
Wilmington, North Carolina, 28401

Other trials in United States

Puerto Rico1 site

Ponce Medical School
Ponce, 00731

Other trials in Puerto Rico

About this study

Official title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial

Read the detailed description

The objective of this US pivotal trial is to investigate the safety and effectiveness of The LimFlow System for creating an AV connection in the Below The Knee (BTK) vascular system using an endovascular, minimally invasive approach to arterialize the pedal veins for the treatment of chronic limb-threatening ischemia (CLTI) in subjects ineligible for conventional endovascular or surgical limb salvage procedures.

Conditions: Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Arterial Occlusive Diseases
Being tested: LimFlow System
Keywords: CLI, CLTI, Amputation, Desert Foot, PAD, Peripheral Artery Disease, Critical Limb Ischemia, Chronic Limb-Threatening Ischemia, TADV - Transcatheter Arterialization of Deep Veins, DVA - Deep Vein Arterialization
Medical subject headings: Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Arterial Occlusive Diseases, Peripheral Vascular Diseases, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LimFlow SystemDevice
Creation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia

Study groups in NCT03970538
Study group	Role	What they receive
Treatment Arm	Experimental	Treated with the LimFlow System Receives: Device: LimFlow System

What is being measured

The primary outcome is the main question the study is designed to answer.

Amputation Free Survival (AFS)
freedom from major amputation and death at 6 months, compared to a historical performance goal.
Measured: 6 months post-procedure

Secondary outcomes (32)

Primary Patency
Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.
Measured: 30 days post procedure
Primary Assisted Patency
Absence of occlusion of the endovascular intervention maintained with the use of additional or secondary surgical or endovascular procedures, as long as occlusion of the primary treated site has not occurred.
Measured: 6 months post-procedure
Secondary Patency
Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.
Measured: 30 days post-procedure
Limb Salvage
The percentage of subjects with freedom from above-ankle amputation of the index limb.
Measured: 30 days post-procedure
Change in Rutherford Classification
A decrease in Rutherford class number (i.e.: from Rutherford class 5 to 4) is clinical improvement
Measured: 30 days post-procedure
Technical Success
The successful creation of an arteriovenous fistula in the desired limb location with immediate morphological success.
Measured: Immediately post-procedure
Procedure Success
Combination of Technical Success, and absence of all-cause death, above-ankle amputation or clinically driven major re-intervention of the stent graft.
Measured: 30 days post-procedure
Target Wound Healing
Complete healing of the patient's target wound
Measured: 30 days post-procedure
All Wound Healing
Complete healing of the patient's wounds.
Measured: 30 days post-procedure
Freedom From Contrast-Induced Nephropathy
Subjects without acute (within 72 hours after intravenous contrast administration) impairment of renal function, measured as an absolute ≥0.5 mg/dL (44 µmol/L) increase compared to baseline SCr value that results in a value above the upper limit of the normal range.
Measured: Within the first 72 hours post-procedure
Procedure Time
Time from the first puncture (venous or arterial) to when the last catheter is removed
Measured: Immediately post-procedure
Radiation Exposure
Patient radiation exposure (measured in milligray)
Measured: During the procedure
Contrast Volume
Total volume of contrast media (measured in milliliters)
Measured: During the procedure
All Wound Area Reduction
Defined as reduction in area of the patient's wounds
Measured: 30 days post-procedure
Primary Patency
Absence of occlusion of the endovascular intervention that is maintained without the need for additional or secondary surgical or endovascular procedures.
Measured: 6 months post procedure
Secondary Patency
Absence of occlusion of the endovascular intervention that is maintained with the use of additional or secondary surgical endovascular procedures after occlusion occurs.
Measured: 6 months post-procedure
Limb Salvage
The percentage of subjects with freedom from above-ankle amputation of the index limb.
Measured: 3 months days post-procedure
Limb Salvage
The percentage of subjects with freedom from above-ankle amputation of the index limb.
Measured: 6 months days post-procedure
Change in Rutherford Classification
A change of one Rutherford class or greater.
Measured: 3 months post-procedure
Change in Rutherford Classification
A change of one Rutherford class or greater.
Measured: 6 months post-procedure
Target Wound Healing
Complete healing of the patient's target wound
Measured: 3 months post-procedure
Target Wound Healing
Complete healing of the patient's target wound
Measured: 6 months post-procedure
Target Wound Healing
Complete healing of the patient's target wound
Measured: 9 months post-procedure
Target Wound Healing
Complete healing of the patient's target wound
Measured: 12 months post-procedure
All Wound Area Reduction
Defined as reduction in area of the patient's wounds
Measured: 3 months post-procedure
All Wound Area Reduction
Defined as reduction in area of the patient's wounds
Measured: 6 months post-procedure
All Wound Area Reduction
Defined as reduction in area of the patient's wounds
Measured: 9 months post-procedure
All Wound Area Reduction
Defined as reduction in area of the patient's wounds
Measured: 12 months post-procedure
All Wound Healing
Complete healing of the patient's wounds.
Measured: 3 months post-procedure
All Wound Healing
Complete healing of the patient's wounds.
Measured: 6 months post-procedure
All Wound Healing
Complete healing of the patient's wounds.
Measured: 9 months post-procedure
All Wound Healing
Complete healing of the patient's wounds.
Measured: 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 201928 Feb 2025

First posted31 May 2019
Study start6 Dec 2019
Primary completion9 Sep 2022
Study completion28 Feb 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Critical Limb IschemiaStudies 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: Not applicable
Intervention model: Single group
Model description: Prospective, multi-center pivotal study
Masking: None (open label)
Enrolment: 105 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03970538
Sponsor's protocol ID: LF-CA-PR-3
Acronym: PROMISE
Status last verified: Jan 2024
First submitted: 29 May 2019
Last updated: 28 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martinez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754.
PubMed 36988592

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
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Nutrition in Patient With Critical Limb Ischemia
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CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
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RecruitingObservational study
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Active, not recruitingPhase 3
Trial to Assess Chelation Therapy in Critical Limb Ischemia
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All Critical Limb Ischemia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia: the PROMISE II Trial
ClinicalTrials.gov ID: NCT03970538
Acronym / sponsor ID: PROMISE / LF-CA-PR-3
Conditions: Critical Limb Ischemia, Critical Lower Limb Ischemia, Peripheral Artery Disease, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Arterial Occlusive Diseases
Keywords: CLI, CLTI, Amputation, Desert Foot, PAD, Peripheral Artery Disease, Critical Limb Ischemia, Chronic Limb-Threatening Ischemia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 105 participants (actual)
Lead sponsor: LimFlow, Inc.Industry (pharma, biotech, devices)
Study start: 6 Dec 2019 (actual)
Primary completion: 9 Sep 2022 (actual)
Study completion: 28 Feb 2025 (estimated)
First posted: 31 May 2019 (actual)
Results: Posted 28 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, multi-center pivotal study

Arm	Type	Receives
Treatment Arm	Experimental	Device: LimFlow SystemTreated with the LimFlow System

Who may qualify

Ages: 18 to 95 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Subject must be ≥18 and ≤ 95 years of age
Clinical diagnosis of chronic limb-threatening ischemia, defined as any of the following clinical assessments: previous angiogram or hemodynamic evidence of severely diminished arterial inflow of the index limb (e.g., ABI ≤ 0.39, TP / TcPO2 < 30 mm Hg) and
Subject has been assessed by the principal investigator, reviewed by the Independent Review Committee (IRC), and determined that no conventional distal bypass surgical or endovascular therapy for limb salvage is feasible due to either a) absence of a usable pedal artery target (endovascular or surgical approach), or b) the presence of a pedal artery target with absence of a viable single-segment vein in either lower extremity or either arm that could be used for autogenous vein conduit.
Proximally, the Target In-flow Artery at the cross-over point must fall within the recommended vessel diameter ranges for the LimFlow stent graft by visual estimation.
Prior stent(s) to the infrainguinal arteries (e.g. iliac, SFA, and popliteal) are allowed.

Key exclusion criteria (15 listed)

Subjects will be excluded from participating in this study if they meet any of the following criteria prior to initiation of the endovascular procedure: Concomitant hepatic insufficiency, thrombophlebitis in the target limb, or non-treatable coagulation disorder within the past 90 days.
Active immunodeficiency disorder or currently receiving immunosuppressant therapy for an immunodeficiency disorder.
Prior peripheral arterial bypass procedure above or below the knee which would inhibit proximal inflow to the stent graft or interventional revascularization procedure within 30 days.
Previous major amputation of the target limb or presence of a wound requiring a free flap or absence of adequate viable tissue.
Life expectancy less than 12 months.

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
LimFlow SystemCreation of an AV fistula in below-the-knee vasculature for the treatment of critical limb ischemia	Device	Treatment Arm

Primary outcome

Amputation Free Survival (AFS)
Time frame: 6 months post-procedure
freedom from major amputation and death at 6 months, compared to a historical performance goal.

32 secondary outcomes

Primary Patency
Time frame: 30 days post procedure
Primary Assisted Patency
Time frame: 6 months post-procedure
Secondary Patency
Time frame: 30 days post-procedure
Limb Salvage
Time frame: 30 days post-procedure
Change in Rutherford Classification
Time frame: 30 days post-procedure
Technical Success
Time frame: Immediately post-procedure
Procedure Success
Time frame: 30 days post-procedure
Target Wound Healing
Time frame: 30 days post-procedure
All Wound Healing
Time frame: 30 days post-procedure
Freedom From Contrast-Induced Nephropathy
Time frame: Within the first 72 hours post-procedure
Procedure Time
Time frame: Immediately post-procedure
Radiation Exposure
Time frame: During the procedure
Contrast Volume
Time frame: During the procedure
All Wound Area Reduction
Time frame: 30 days post-procedure
Primary Patency
Time frame: 6 months post procedure
Secondary Patency
Time frame: 6 months post-procedure
Limb Salvage
Time frame: 3 months days post-procedure
Limb Salvage
Time frame: 6 months days post-procedure
Change in Rutherford Classification
Time frame: 3 months post-procedure
Change in Rutherford Classification
Time frame: 6 months post-procedure
Target Wound Healing
Time frame: 3 months post-procedure
Target Wound Healing
Time frame: 6 months post-procedure
Target Wound Healing
Time frame: 9 months post-procedure
Target Wound Healing
Time frame: 12 months post-procedure
All Wound Area Reduction
Time frame: 3 months post-procedure
All Wound Area Reduction
Time frame: 6 months post-procedure
All Wound Area Reduction
Time frame: 9 months post-procedure
All Wound Area Reduction
Time frame: 12 months post-procedure
All Wound Healing
Time frame: 3 months post-procedure
All Wound Healing
Time frame: 6 months post-procedure
All Wound Healing
Time frame: 9 months post-procedure
All Wound Healing
Time frame: 12 months post-procedure

Results and safety

Results posted to the registry on 28 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	105	105

Primary outcome: Amputation Free Survival (AFS)

Time frame: 6 months post-procedure. Number. Unit: Percentage of participants

Measure	Treatment n = 105
Value	66

32 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	68 of 105 (64.8%)	98 of 105 (93.3%)	12 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36988592Shishehbor MH, Powell RJ, Montero-Baker MF, Dua A, Martinez-Trabal JL, Bunte MC, Lee AC, Mugglin AS, Mills JL, Farber A, Clair DG; PROMISE II Investigators. Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia. N Engl J Med. 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754.
Individual participant dataSharing planned: No

Related trials for Critical Limb Ischemia

Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
RecruitingEarly Phase 1
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CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
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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.

Daniel Clair, MD principal investigator

Vanderbilt University

Mehdi Shishehbor principal investigator

University Hospital Cleveland

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LimFlow System in people with Critical Limb Ischemia and Critical Lower Limb Ischemia, run by LimFlow, Inc. at 21 sites in 2 countries.

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 18 inclusion and 15 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Puerto Rico. 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?

Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amputation Free Survival (AFS) (time frame: 6 months post-procedure). 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 NCT03970538, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 26 Oct 2026.