In-stent RestenosisRESTONCT04268875
Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT
A study testing Optical Coherence Tomography (OCT) in people with In-stent Restenosis, run by University Hospital, Clermont-Ferrand at 27 sites in 3 countries.
Trial summary
The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents (drug-eluting stents: DES). The number and clinical lifespan of stents implanted over the last twenty-five years, however, explain the fact that restenosis remains a not unusual clinical problem… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Restenosis
- What is being tested?
- Optical Coherence Tomography (OCT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 27 sitesin 3 countries
- Study dates
- 11 Dec 2019to 6 Dec 2022
- 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
- Men or women, aged 18 years and over.
- Uncoated, coated or bioresorbable stent restenosis, defined by lumen obstruction of over 50% in the stent and/or within 5 mm proximal or distal to the stent found on coronary angiography.
- Patients treated for an acute coronary syndrome in which restenosis is suspected. It is recommended that OCT be performed after restoring TIMI grade 3 coronary flow in the initial investigation or in a later review at < 7 days.
- Patient informed consent.
- Subscription to a social security system.
Who cannot join
- Technical inability to perform the OCT (distal lesions, severe chronic renal failure).
- Contraindication to the use of ABBOTT systems when insertion of any type of catheter represents a risk to the patient. The contraindications include the following:
- Bacteraemia or septicaemia
- Significant coagulation system abnormalities
- Patients in whom coronary artery spasm has been diagnosed
- Patients who do not meet the criteria for coronary artery bypass grafting
Show all 12Show fewer
- Patients who do not meet the criteria for percutaneous coronary angioplasty
- Severe haemodynamic shock or instability
- Total occlusion
- Life expectancy of under one year for non-cardiac reasons.
- Pregnant or breast-feeding women or women who are fertile and not taking appropriate contraceptives.
- Patients under legal protection or guardianship
Trial locations and contacts
27 sites in 3 countries.
27 sites in 3 countries
France24 sites
Clinique la Roseraie
Aubervilliers
CH Avignon
Avignon
CHRU Besançon
Besançon
CHU Bordeaux
Bordeaux
CHRU Morvan
Brest
Hôpital privé saint Martin
Cauro
Centre Hospitalier les Hôpitaux de Chartres
Chartres
CHU Clermont Ferrand
Clermont-Ferrand, Auvergne, 63000
CHRU Grenoble Alpes
Grenoble
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
CHRU Lille
Lille
Centre Hospitalier Saint Joseph Saint Luc
Lyon
Hospices Civiles Lyon
Lyon
AP-HM
Marseille
CHRU Nîmes
Nîmes
Polyclinique les fleurs
Ollioules
AP-HP
Paris
Hôpital Privé Institut Mutualiste Montsouris
Paris
CHRU Poitiers
Poitiers
Clinique Saint Hilaire
Rouen
CHRU Strasbourg
Strasbourg
Clinique Pasteur Toulouse
Toucy
CHRU Toulouse
Toulouse
CHRU Hôpitaux de Tours
Tours
About this study
The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents (drug-eluting stents: DES). The number and clinical lifespan of stents implanted over the last twenty-five years, however, explain the fact that restenosis remains a not unusual clinical problem which is expressed as a recurrence of angina or of an acute coronary syndrome (ACS).
The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred. In symptomatic stent restenosis (angina or acute coronary syndrome), a further angioplasty is usually required, occasionally on an emergency basis. Coronary angiography is often not capable of explaining the mechanical causes of this complication.
Read more
Optical coherence tomography (OCT), a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment. OCT during angiography provides a detailed analysis of the stents and potential complications: the presence of neoatherosclerosis with or without plaque rupture, intimal hyperplasia, stent under-deployment, stent fracture and distal or proximal progression of the atherosclerosis.
The investigators propose a prospective, multicentre study of all cases of intrastent restenosis, examined by angiography, causing clinical features involving stable angina and acute coronary syndrome. The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis. The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment. There are several possible treatments for restenosis, including balloon angioplasty, coated balloon angioplasty, stenting or aorto-coronary bypass graft surgery.
Read the detailed description
All stented coronary artery patients hospitalised for stable angina or an ACS requiring a further coronary angiogram (regardless of time since implantation or type of the initial stent) identified to have intrastent restenosis during coronary angiography will be included after being informed and obtaining their informed written consent.
- For cases of stable angina the OCT the will be performed immediately with insertion of the probe distal to the area being studied and then automatic retraction of the fibre during injection of the contrast medium.
- For ACS, the OCT will be performed immediately or on a deferred basis at the discretion of the operator.
- For critical lesions which prevent the OCT fibre passing across the lesion, "soft" predilatation with a 2 mm or smaller balloon is permitted.
- Practical conduct of the OCT:
- Pullback at baseline state and analysis of the stent with a 5 mm margin proximal and distal to the lesion.
- OCT analysis: under-deployment of the stent (expansion < 80% of the reference mean surface area), neoatherosclerosis with or without rupture, homogeneous or non-homogeneous hyperplasia, stent fracture and proximal or distal progression of the atherosclerosis.
- Final pullback in cases of a new angioplasty (balloon angioplasty, angioplasty with a coated balloon or stenting).
- The OCT investigations will be anonymised and registered in their original format with a view to centralised reading (Corelab ISIT, UMR 6284-CNRS, Clermont-Ferrand University).
- The angiography records will be submitted for reading by a panel blinded to the OCT for the purposes of demonstrating the added value of OCT in the fine details of diagnosis and the impact of a treatment decision. The angiograms will be reviewed in a centralised analytical laboratory, which will re-read the procedures blind.
- Patients will be followed up via telephone contact or visit one year after inclusion into the study to record any complications which have developed (possible myocardial infarction, reason, any new revascularisation of the target lesion or another artery and reason for this, any deaths and their causes).
- Conditions
- In-stent Restenosis
- Being tested
- Optical Coherence Tomography (OCT)
- Keywords
- In-stent restenosis, optical coherence tomography (OCT), coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography (OCT)Device
The OCT fibre is an optical fibre catheter containing a lens located at its extremity and positioned distal to the arterial segment to be examined. This is an intracoronary, very high-resolution section technique based on absorption and reflection of close infrared light by stents and tissues.
OCT analysis is performed during a usual coronary angiography procedure. It is a common technique already used and recommended for intrastent restenosis to establish the mechanism of the process. No new product is being tested. The examination performed is the same.
| Study group | Role | What they receive |
|---|---|---|
| OCT | Experimental | Patient witch coronary artery disease who has been stented and is hospitalised for stable angina or acute coronary syndrome requiring a further coronary angiogram (regardless of time since implantation or type of the initial stent.
- Identification of intrastent restenosis during coronary angiography and realisation of an immediate or deferred OCT. Receives: Device: Optical Coherence Tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Under-deployment of the stent with percentage under-deployment is defined when the minimum intrastent surface area is less than 80% of the reference surface area.
Measured: day 0
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Homogeneous or non-homogeneous intimal hyperplasia.
Measured: day 0
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Presence of neoatherosclerosis, with or without rupture.
Measured: day 0
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Stent fracture .
Measured: day 0
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Progression of the proximal or distal atherosclerosis .
Measured: day 0
Secondary outcomes (28)
Clinical data
time to onset of intrastent restenosis
Measured: day 0
Clinical data
sex
Measured: day 0
Clinical data
age
Measured: day 0
Clinical data
past history of angioplasty
Measured: day 0
Clinical data
myocardial infarction
Measured: day 0
Clinical data
coronary artery bypass grafting
Measured: day 0
Clinical data
multi-vessel disease
Measured: day 0
Clinical data
prosthetic valve
Measured: day 0
Clinical data
heart failure
Measured: day 0
Clinical data
chronic renal failure
Measured: day 0
Clinical data
atrial fibrillation
Measured: day 0
Clinical data
valve disease
Measured: day 0
Clinical data
vascular disease
Measured: day 0
Clinical data
CVA
Measured: day 0
Clinical data
TIA
Measured: day 0
Cardiovascular risk factors
hypertension
Measured: day 0
Cardiovascular risk factors
dyslipidaemia
Measured: day 0
Cardiovascular risk factors
diabetes
Measured: day 0
Cardiovascular risk factors
family history
Measured: day 0
Cardiovascular risk factors
overweight (BMI > 25)
Measured: day 0
Cardiovascular risk factors
smoking habit
Measured: day 0
Blood sample
Measure of LDL cholesterol
Measured: day 0, day 365
Blood sample
Measure of HDL cholesterol
Measured: day 0, day 365
Blood sample
Measure of triglycerides
Measured: day 0, day 365
Blood sample
Measure of HbA1c
Measured: day 0, day 365
Blood sample
Measure of creatinine
Measured: day 0, day 365
Blood sample
Measure of renal clearance
Measured: day 0, day 365
New revascularisation events
new revascularisation event in the target lesion or another artery, myocardial infarctions, deaths and causes of events
Measured: day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start11 Dec 2019
- Primary completion6 Dec 2022
- Study completion6 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for In-stent RestenosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Corelab ISIT
- Responsible party
- Sponsor
- Investigators
- Géraud Souteyrand, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268875
- Sponsor's protocol ID
- RBHP 2019 SOUTEYRAND
- Other IDs
- 2019-A02305-52
- Acronym
- RESTO
- Status last verified
- Apr 2023
- First submitted
- 10 Feb 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Souteyrand G, Mouyen T, Honton B, Mulliez A, Lattuca B, Dilinger JG, Levesque S, Range G, Combaret N, Marliere S, Lamallem O, Quillot M, Gerbaud E, Motreff P, Amabile N. Stent Underexpansion Is an Underestimated Cause of Intrastent Restenosis: Insights From RESTO Registry. J Am Heart Assoc. 2024 Nov 5;13(21):e036065. doi: 10.1161/JAHA.124.036065. Epub 2024 Oct 25.
PubMed 39450717
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT
- ClinicalTrials.gov ID
- NCT04268875
- Acronym / sponsor ID
- RESTO / RBHP 2019 SOUTEYRAND
- Conditions
- In-stent Restenosis
- Keywords
- In-stent restenosis, optical coherence tomography (OCT), coronary angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Abbott, Corelab ISIT
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 6 Dec 2022 (actual)
- Study completion
- 6 Dec 2022 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents (drug-eluting stents: DES). The number and clinical lifespan of stents implanted over the last twenty-five years, however, explain the fact that restenosis remains a not unusual clinical problem which is expressed as a recurrence of angina or of an acute coronary syndrome (ACS).
The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred. In symptomatic stent restenosis (angina or acute coronary syndrome), a further angioplasty is usually required, occasionally on an emergency basis. Coronary angiography is often not capable of explaining the mechanical causes of this complication.
Optical coherence tomography (OCT), a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment. OCT during angiography provides a detailed analysis of the stents and potential complications: the presence of neoatherosclerosis with or without plaque rupture, intimal hyperplasia, stent under-deployment, stent fracture and distal or proximal progression of the atherosclerosis.
The investigators propose a prospective, multicentre study of all cases of intrastent restenosis, examined by angiography, causing clinical features involving stable angina and acute coronary syndrome. The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis. The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment. There are several possible treatments for restenosis, including balloon angioplasty, coated balloon angioplasty, stenting or aorto-coronary bypass graft surgery.
Detailed description
All stented coronary artery patients hospitalised for stable angina or an ACS requiring a further coronary angiogram (regardless of time since implantation or type of the initial stent) identified to have intrastent restenosis during coronary angiography will be included after being informed and obtaining their informed written consent.
- For cases of stable angina the OCT the will be performed immediately with insertion of the probe distal to the area being studied and then automatic retraction of the fibre during injection of the contrast medium.
- For ACS, the OCT will be performed immediately or on a deferred basis at the discretion of the operator.
- For critical lesions which prevent the OCT fibre passing across the lesion, "soft" predilatation with a 2 mm or smaller balloon is permitted.
- Practical conduct of the OCT:
- Pullback at baseline state and analysis of the stent with a 5 mm margin proximal and distal to the lesion.
- OCT analysis: under-deployment of the stent (expansion < 80% of the reference mean surface area), neoatherosclerosis with or without rupture, homogeneous or non-homogeneous hyperplasia, stent fracture and proximal or distal progression of the atherosclerosis.
- Final pullback in cases of a new angioplasty (balloon angioplasty, angioplasty with a coated balloon or stenting).
- The OCT investigations will be anonymised and registered in their original format with a view to centralised reading (Corelab ISIT, UMR 6284-CNRS, Clermont-Ferrand University).
- The angiography records will be submitted for reading by a panel blinded to the OCT for the purposes of demonstrating the added value of OCT in the fine details of diagnosis and the impact of a treatment decision. The angiograms will be reviewed in a centralised analytical laboratory, which will re-read the procedures blind.
- Patients will be followed up via telephone contact or visit one year after inclusion into the study to record any complications which have developed (possible myocardial infarction, reason, any new revascularisation of the target lesion or another artery and reason for this, any deaths and their causes).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT | Experimental | Device: Optical Coherence Tomography (OCT)Patient witch coronary artery disease who has been stented and is hospitalised for stable angina or acute coronary syndrome requiring a further coronary angiogram (regardless of time since implantation or type of the initial stent. - Identification of intrastent restenosis during coronary angiography and realisation of an immediate or deferred OCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women, aged 18 years and over.
- Uncoated, coated or bioresorbable stent restenosis, defined by lumen obstruction of over 50% in the stent and/or within 5 mm proximal or distal to the stent found on coronary angiography.
- Patients treated for an acute coronary syndrome in which restenosis is suspected. It is recommended that OCT be performed after restoring TIMI grade 3 coronary flow in the initial investigation or in a later review at < 7 days.
- Patient informed consent.
- Subscription to a social security system.
Key exclusion criteria (12 listed)
- Technical inability to perform the OCT (distal lesions, severe chronic renal failure).
- Contraindication to the use of ABBOTT systems when insertion of any type of catheter represents a risk to the patient. The contraindications include the following:
- Life expectancy of under one year for non-cardiac reasons.
- Pregnant or breast-feeding women or women who are fertile and not taking appropriate contraceptives.
- Patients under legal protection or guardianship
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 |
|---|---|---|
| Optical Coherence Tomography (OCT)The OCT fibre is an optical fibre catheter containing a lens located at its extremity and positioned distal to the arterial segment to be examined. This is an intracoronary, very high-resolution section technique based on absorption and reflection of close infrared light by stents and tissues. OCT analysis is performed during a usual coronary angiography procedure. It is a common technique already used and recommended for intrastent restenosis to establish the mechanism of the process. No new product is being tested. The examination performed is the same. | Device | OCT |
Primary outcome
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Time frame: day 0
Under-deployment of the stent with percentage under-deployment is defined when the minimum intrastent surface area is less than 80% of the reference surface area.
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Time frame: day 0
Homogeneous or non-homogeneous intimal hyperplasia.
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Time frame: day 0
Presence of neoatherosclerosis, with or without rupture.
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Time frame: day 0
Stent fracture .
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis
Time frame: day 0
Progression of the proximal or distal atherosclerosis .
28 secondary outcomes
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Clinical data
Time frame: day 0
Cardiovascular risk factors
Time frame: day 0
Cardiovascular risk factors
Time frame: day 0
Cardiovascular risk factors
Time frame: day 0
Cardiovascular risk factors
Time frame: day 0
Cardiovascular risk factors
Time frame: day 0
Cardiovascular risk factors
Time frame: day 0
Blood sample
Time frame: day 0, day 365
Blood sample
Time frame: day 0, day 365
Blood sample
Time frame: day 0, day 365
Blood sample
Time frame: day 0, day 365
Blood sample
Time frame: day 0, day 365
Blood sample
Time frame: day 0, day 365
New revascularisation events
Time frame: day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39450717Souteyrand G, Mouyen T, Honton B, Mulliez A, Lattuca B, Dilinger JG, Levesque S, Range G, Combaret N, Marliere S, Lamallem O, Quillot M, Gerbaud E, Motreff P, Amabile N. Stent Underexpansion Is an Underestimated Cause of Intrastent Restenosis: Insights From RESTO Registry. J Am Heart Assoc. 2024 Nov 5;13(21):e036065. doi: 10.1161/JAHA.124.036065. Epub 2024 Oct 25.
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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.
Géraud Souteyrand principal investigator
University Hospital, Clermont-Ferrand
27 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography (OCT) in people with In-stent Restenosis, run by University Hospital, Clermont-Ferrand at 27 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Switzerland, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis (time frame: day 0). The study lists 5 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 NCT04268875, 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 18 Apr 2023.