Critical Limb Ischemia (CLI)NCT05208905
LIFE-BTK PK Sub-study
A study testing Esprit BTK Device in people with Critical Limb Ischemia (CLI), run by Abbott Medical Devices at 5 sites in 3 countries.
Trial summary
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia (CLI)
- What is being tested?
- Esprit BTK Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Feb 2022to 22 Feb 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Subject must provide written informed consent prior to any clinical investigation related procedure
- Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5
- Subject requires primary treatment of one or more de novo or restenotic (treated with prior PTA) infrapopliteal lesions
- Subject must be at least 18 years of age
- Female subject of childbearing potential should not be pregnant and must be on birth control Note: Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Show all 17Show fewer
- Anatomic Inclusion Criteria:
- One or more native infrapopliteal lesions, including de novo lesions in the same limb. Restenotic (from prior PTA) lesions are allowed.
- Lesion must be located in the proximal 2/3 of native infrapopliteal vessels, with vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm by investigator visual assessment.
- Total scaffold length to completely cover/treat target lesion(s) must be between 170 and 256 mm (maximum total everolimus drug dose of 2714 µg).
- The target vessel can have any other angiographic significant lesions (≥50%) that should be treated per institution standard of care prior to treatment of the target lesion.
- Tandem lesions are allowed and the total scaffold length used to cover the entire diseased segment must be ≤ 256 mm.
- Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography, IVUS, and/or OCT) can be used to aid accurate sizing of the vessels.
- The distal margin of the scaffold must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. If the vessel segment distal to the target lesion has a significant lesion (> 50% stenosis), it should be treated per institution standard of care prior to deployment of the scaffold.
- Significant lesion (≥ 50% stenosis) in the inflow artery(ies) must be treated successfully (as per physician's assessment of the angiography) through standard of care prior to the treatment of the target lesion. Treatment must be done within the same trial procedure. Treatment allowed for inflow artery lesions are PTA, atherectomy, cutting/scoring balloon, Shockwave balloon, bare metal stent, drug-eluting stents or drug-coated balloon. Everolimus-coated or eluting devices are not allowed.
- It is acceptable for non-target lesion(s) (if applicable) to be located in the same infrapopliteal vessel(s) as the target lesion, and suitable to be treated per institution standard of care. Non-target lesions must be treated successfully prior to target lesions and not requiring re-cross of the scaffold.
- Crossing of the target lesion in an antegrade fashion is preferred, but retrograde crossing may be used. However, the treatment must be delivered antegrade.
Who cannot join
- General Exclusion Criteria:
- Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- Subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or subject has had major amputation to the contralateral extremity < 1 year prior to index procedure and is not independently ambulating.
Show all 45Show fewer
- Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
- Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants such as heparin or bivalirudin, and therefore cannot be adequately treated with study medications. Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications, within 12 months after index procedure. Planned amputation that will necessitate discontinuation of antiplatelet medications is allowed.
- Subject has life expectancy ≤ 1 year.
- Subject has had a stroke within the previous 3 months with residual Rankin score of ≥ 2.
- Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min per 1.73m^2.
- Subject is currently on dialysis.
- Subject has platelet count < 100,000 cells/mm^3 or > 700,000 cells/mm^3, a WBC < 3,000 cells/mm^3, or hemoglobin < 9.0 g/dl.
- Subject has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease, that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.), or subject is receiving immunosuppression therapy for other conditions. Subjects treated for HIV (Human Immunodeficiency Virus) and who have undetectable viral load, such that their immune system is not considered compromised, are eligible.
- Subject has Body Mass Index (BMI) <18.
- Subject is receiving or scheduled to receive anticancer therapy for malignancy within 6 months prior to index procedure or within 1 year after the procedure. Patients taking medications classified as chemotherapy but who have been in remission for at least 6 months are eligible.
- Subject has coagulation disorder that increases the risk of arterial thrombosis. Subjects with deep vein thrombosis and disorders that increase the risk of deep vein thrombosis can be included in the study.
- Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.
- Subject has previously had, or requires surgical revascularization involving any vessel of the ipsilateral extremity. Prior femoropopliteal or aortobifemoral bypass is allowed. Any bypass to the tibial arteries is not allowed.
- Subject has signs or symptoms of advanced limb infection or septicemia (fever > 38.5, WBC > 15,000 cells/microliter, hypotension) at the time of assessment. Osteomyelitis of the phalanges or metatarsal heads (as described in exclusion criteria #21a) or cellulitis of the foot amenable to treatment with IV antibiotics at the time of revascularization is acceptable.
- Subject is bedridden or unable to walk (with assistance is acceptable). Subjects in wheelchair who are able to mobilize on their own can be enrolled.
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputations. This includes subjects with:
- Osteomyelitis that extends proximal to the metatarsal heads. Osteomyelitis limited to the phalanges or metatarsal heads is acceptable for enrollment.
- Gangrene involving the plantar skin of the forefoot, midfoot, or heel
- Deep ulcer or large shallow ulcer (> 3 cm) involving the plantar skin of the forefoot, midfoot, or heel
- Full thickness heel ulcer with/without calcaneal involvement
- Any wound with calcaneal bone involvement
- Wounds that are deemed to be neuropathic or non-ischemic in nature
- Wounds that would require flap coverage or complex wound management for large soft tissue defect
- Full thickness wounds on the dorsum of the foot with exposed tendon or bone.
- Subject is unable or unwilling to provide written consent prior to enrollment
- Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months
- Anatomic Exclusion Criteria:
- Lesions with severe calcification, in which there is a high likelihood that successful pre-dilatation cannot be achieved.
- Lesion that has prior metallic stent implant.
- Coronary or peripheral artery treated with everolimus-eluting device during index procedure, or within 90 days prior to index procedure.
- Target or (if applicable) non-target vessel contains visible thrombus as indicated in the angiographic images.
- Subject has angiographic evidence of thromboembolism or atheroembolism in the ipsilateral extremity. (Pre- and post-angiographic imaging must confirm the absence of emboli in the distal anatomy.)
- Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
- No angiographic evidence of a patent pedal artery.
- Target or (if applicable) non-target lesion location requiring bifurcation treatment method that requires scaffolding of both branches (provisional treatment, without intention of scaffolding both branches is acceptable).
- Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.
- Visual assessment of the target lesion suggests that the investigator is unable to pre-dilate the lesion according to the vessel diameter.
- Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.
- Note: staged procedures are not allowed in LIFE-BTK PK sub-study.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Ascension St. John Jane Phillips
Bartlesville, Oklahoma, 74006
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
Charlton Memorial Hospital
South Dartmouth, Massachusetts, 02747
About this study
Official title: LIFE-BTK Pharmacokinetics (PK) Sub-study
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Of the 7 subjects planned to be enrolled, 4 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom drug-coated balloons (DCB) were not used; 3 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom DCB were used for treatment of inflow disease.
- Conditions
- Critical Limb Ischemia (CLI)
- Being tested
- Esprit BTK Device
- Keywords
- Infrapopliteal lesions, Esprit BTK Everolimus Eluting Bioresorbable Scaffold System
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esprit BTK DeviceDevice
Participants will receive Esprit BTK Device
| Study group | Role | What they receive |
|---|---|---|
| Esprit BTK | Experimental | Participants who receives Esprit BTK device will be included in this arm Receives: Device: Esprit BTK Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Blood Everolimus Concentration (Cmax)
Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 60 day period of the study after assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
Measured: 0 to 60 days
Area Under the Blood Concentration Time Curve From Administration to the Concentration at 24 Hours (AUC0-24h)
Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post Esprit BTK implantation. Calculated by the Lin Up Log Down trapezoidal method.
Measured: 0 to 24 hours
Area Under the Blood Concentration Time Curve From Administration to Last Observed Concentration at Time t (AUCt)
Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.
Measured: 0 to 60 days
Area Under the Blood Everolimus Concentration vs. Time Curve From Time Zero and Extrapolated to Infinity (AUCinf)
Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
calculated as: AUC0-∞ = AUClast + (Clast/λz)
The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as:
%AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100
Measured: 0 to 60 days
Time to Reach Maximum Observed Whole-Blood Concentration (Tmax)
Time to reach the maximal observed blood analyte concentration during the 60 day period of the study after assessing at different time frames (0 minute,10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
Measured: 0 to 60 days
Terminal Elimination Half-life (t1/2term)
The apparent terminal elimination half-life, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
calculated as: t1/2term = 0.693/λz.
Measured: 0 to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start10 Feb 2022
- Primary completion18 Apr 2023
- Study completion22 Feb 2028 (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.
- Other trials for Critical Limb Ischemia (CLI)Studies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208905
- Sponsor's protocol ID
- ABT-CIP-10293 Ver. B
- Status last verified
- Jan 2026
- First submitted
- 13 Jan 2022
- Last updated
- 26 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFE-BTK Pharmacokinetics (PK) Sub-study
- ClinicalTrials.gov ID
- NCT05208905
- Acronym / sponsor ID
- ABT-CIP-10293 Ver. B
- Conditions
- Critical Limb Ischemia (CLI)
- Keywords
- Infrapopliteal lesions, Esprit BTK Everolimus Eluting Bioresorbable Scaffold System
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 22 Feb 2028 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Posted 26 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Of the 7 subjects planned to be enrolled, 4 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom drug-coated balloons (DCB) were not used; 3 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom DCB were used for treatment of inflow disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esprit BTK | Experimental | Device: Esprit BTK DeviceParticipants who receives Esprit BTK device will be included in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject must provide written informed consent prior to any clinical investigation related procedure
- Subject has symptomatic Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5
- Subject requires primary treatment of one or more de novo or restenotic (treated with prior PTA) infrapopliteal lesions
- Subject must be at least 18 years of age
- Female subject of childbearing potential should not be pregnant and must be on birth control Note: Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
Key exclusion criteria (45 listed)
- Subject is currently participating in another clinical investigation that has not yet completed its primary endpoint.
- Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Incapacitated individuals, defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
- Subject has had any amputation to the ipsilateral extremity other than the toe or forefoot, or subject has had major amputation to the contralateral extremity < 1 year prior to index procedure and is not independently ambulating.
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 |
|---|---|---|
| Esprit BTK DeviceParticipants will receive Esprit BTK Device | Device | Esprit BTK |
Primary outcome
Maximal Blood Everolimus Concentration (Cmax)
Time frame: 0 to 60 days
Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 60 day period of the study after assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
Area Under the Blood Concentration Time Curve From Administration to the Concentration at 24 Hours (AUC0-24h)
Time frame: 0 to 24 hours
Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post Esprit BTK implantation. Calculated by the Lin Up Log Down trapezoidal method.
Area Under the Blood Concentration Time Curve From Administration to Last Observed Concentration at Time t (AUCt)
Time frame: 0 to 60 days
Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.
Area Under the Blood Everolimus Concentration vs. Time Curve From Time Zero and Extrapolated to Infinity (AUCinf)
Time frame: 0 to 60 days
Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ * 100
Time to Reach Maximum Observed Whole-Blood Concentration (Tmax)
Time frame: 0 to 60 days
Time to reach the maximal observed blood analyte concentration during the 60 day period of the study after assessing at different time frames (0 minute,10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
Terminal Elimination Half-life (t1/2term)
Time frame: 0 to 60 days
The apparent terminal elimination half-life, reached during the 60 day period of the study. After assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation). calculated as: t1/2term = 0.693/λz.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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LIFE-BTK Randomized Controlled Trial
Critical Limb Ischemia (CLI)
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esprit BTK Device in people with Critical Limb Ischemia (CLI), run by Abbott Medical Devices at 5 sites in 3 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 17 inclusion and 45 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, Taiwan. 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 26 Jan 2026). 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?
Maximal Blood Everolimus Concentration (Cmax) (time frame: 0 to 60 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.