NCT05946629ClinicalTrials.gov

SELUTION 4 De Novo Small Vessel IDE Trial

A Prospective Randomized Single-Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 PTCA Drug Eluting Balloon in the Treatment of Subjects With De Novo Coronary Lesions in Small Vessels

En recrutementAccepte des participants actuellement, selon la fiche du registre.

Contacter cette étude

En bref

Interventionnelle960 participants recherchés70 sites2 pays

Catégories

Cardiovasculaire100%

Enregistré dans 1 registre

ClinicalTrials.govNCT05946629Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-07-14; recorded start 2023-10-20
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 6 other studies in this databaseCounted from the lead sponsor named in the record (M.A. Med Alliance S.A.)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding13/20
Double-blind
Control arm15/15
Active-comparator control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 70 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 960 participants (target), run at 70 sites, across 2 countries.

How this score is built

Enrolment29/40
960 participants (target)
Site count21/25
70 sites
Country count7/15
2 countries
Planned duration10/10
Planned over about 93 months
Sponsor scale3/10
M.A. Med Alliance S.A. has led 7 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US.

Prospective, randomized controlled, single-blind, multicenter, clinical trial The study will enroll up to 910 randomized subjects, up to 30 subjects in a parallel angiographic substudy, and up to 20 subjects in a parallel pharmacokinetic (pK) substudy, at up to 80 sites in the US, Canada, Brazil, Japan and Europe. A minimum of 50% of the subjects will be enrolled in the US. Subjects who present with chronic coronary syndrome (CCS), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) with an indication for percutaneous coronary intervention (PCI) with planned intervention for de novo lesions in small coronary vessels (RVD 2.00 mm to 2.75 mm) and meeting all eligibility criteria will be randomized 1:1 to treatment of the identified target lesion with either the SELUTION SLR 014 PTCA DEB or contemporary DES. Randomized Cohort: * Intervention (DEB Strategy): Subjects randomized to the SELUTION SLR 014 PTCA DEB arm will receive lesion preparation according to the 3rd drug coated balloon (DCB) consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, intravascular lithotripsy, laser, rotational or orbital atherectomy, cutting or scoring balloon at the discretion of the operator as needed to reduce diameter stenosis to ≤ 30%). Subjects with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis \> 30%) will receive a DES instead of the SELUTION DEB but remain in the SELUTION DEB group (intention to treat analysis). The DEB should not be used after DES implant. * Control (DES): Subjects randomized to the DES arm will receive treatment using any FDA approved "limus-based" DES, as per standard institutional practice. Angiographic Substudy: The angiographic substudy is a parallel registry consisting of up to 30 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. These subjects will undergo angiography at 12 months post-procedure. Clinical follow-up will not extend beyond 12 months in this cohort. Pharmacokinetic (pK) Substudy: The pKsubstudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. This study will be conducted under an approved substudy protocol and will include blood draws at regular intervals to characterize the pK plasma profile of sirolimus. Primary Endpoint: Target lesion failure (TLF), defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months. MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.

Affections

Coronary Artery Disease

Éligibilité

Éligibilité
Sexe	Tous
Âges	18 Years – Aucun maximum
Volontaires sains	Non

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * Clinical Inclusion Criteria Subjects must meet all of the following clinical criteria to participate in the trial: 1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations). 2. Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure or are using a contraceptive device or drug. 3. Subject presents with chronic coronary syndromes \[CCS\] (manifest as documented angina or positive functional testing), unstable angina or stabilized non-ST elevation myocardial infarction (NSTEMI) (biomarkers stabilized or down trending) with an indication for PCI and planned intervention. 4. Subject can tolerate dual antiplatelet therapy with aspirin, plus either Clopidogrel, Prasugrel, or Ticagrelor. (Note: For subjects requiring oral anticoagulation, aspirin may be omitted based on investigator discretion). 5. Subject has life expectancy \> 1 year in the opinion of the investigator. 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. PK Sub- Study Inclusion Criteria: Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria: 1\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations. Imaging Inclusion Criteria Subject's target lesion(s) must meet all of the following angiographic criteria for the subject to participate in the trial: 1. A single, target lesions that meet criteria can be treated in a single vessel. No non-target lesions can be treated within the target vessel in the index procedure. Non-target lesions within the target vessel can be staged for treatment \> 30 days from the index procedure. 2. Up to two (2) non-target lesions in up to two (2) non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before randomization and treatment of the target lesion. 3. Target lesion is ≤ 36 mm in length. 4. Target lesion has diameter stenosis \> 50% and ≤ 99% with distal flow at least thrombolysis in myocardial infarction (TIMI) 2. 5. Target vessel has RVD of ≥ 2.00 mm and ≤ 2.75 mm \[by visual assessment\]. 6. Target lesion is within a native coronary artery or major branch. 7. A target lesion within a bifurcation is allowed only if a single vessel (either main vessel or side branch) is to be treated. 8. The identified target lesion has high probability for successful treatment with approved pre-treatment techniques and DEB alone based on Investigator assessment. Exclusion Criteria: * Clinical Exclusion Criteria Subjects who meet any of the following clinical criteria will be excluded from the trial: 1. Subject with known hypersensitivity or allergy to Sirolimus or its analogues. 2. Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically instable. 3. Subject with history of ST-elevation myocardial infarction (STEMI) within 30 days of the index procedure. 4. Subject with planned major surgery within 30 days following the index procedure. 5. Subject with planned treatment of lesion involving aorto-ostial location. 6. Subject with PCI of a non-target vessel within ± 30 days of the index procedure. 7. Subject with history (within 6 months prior to index procedure) of New York Heart Association (NYHA) class III or IV heart failure. 8. Subject with history of active peptic ulcer or gastrointestinal bleeding within 6 months of the index procedure or other inability to comply with the recommended duration of dual antiplatelet therapy (DAPT). 9. Subject is pregnant, breast-feeding or a woman of childbearing potential who plans pregnancy up to 1 year following index procedure. 10. Subjects with current documented left ventricular ejection fraction (LVEF) \< 30%. 11. Subject is considered not able to tolerate at least 30 seconds of coronary occlusion for the target lesion treated. 12. Subjects is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. 13. Subject with definite clinically active COVID-19 infection defined as a positive COVID test within 24 hours of index procedure. 14. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or had undergone renal transplantation. PK Sub-Study Exclusion Criteria: Subjects must meet none of the main protocol exclusion criteria to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met: 1. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure. 2. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure (Exclusion #6 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study. 3. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason. 4. Subject is concurrently enrolled in the main protocol angiographic registry. 5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir. 6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort. * Angiographic Exclusion Criteria Subject whose target lesion(s) meet any of the following angiographic criteria will be excluded from the trial: 1. Target lesion is totally occluded or has evidence of thrombus. 2. Target lesion is located in the left main or any arterial or venous graft. 3. Target lesion is in a side branch that is "jailed" by a main vessel stent. 4. In stent restenosis

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étude	Interventionnelle
Phase	Sans objet
Répartition	Randomisée
Modèle d'intervention	PARALLEL
Objectif principal	TREATMENT
Insu	DOUBLE (2)
Recrutement	960 participants recherchés

Promoteur et collaborateurs

M.A. Med Alliance S.A. Promoteur
NAMSA Collaborateurs
Cordis US Corp. Collaborateurs

Groupes et interventions

SELUTION SLR 014 PTCA DEBEXPERIMENTAL
SELUTION Sustained Limus Release (SLR) 014 Percutaneous Transluminal Coronary Angioplasty (PTCA) Drug Eluting Balloon (DEB) The SELUTION SLR 014 PTCA DEB is a minimally invasive, single use and sterile Sirolimus coated PTCA balloon catheter. The SELUTION SLR 014 PTCA DEB is available with balloon diameters from 2.0 to 3.0 mm and lengths of 15 to 40 mm for the purpose of the De Novo IDE trial
Control TreatmentACTIVE_COMPARATOR
any FDA approved "limus-based" Drug Eluting Stent, as per standard institutional practice

Interventions

Dispositif PCI with FDA approved "-limus" DES
For subjects randomized to the control group (DES), the treating physician will choose an FDA cleared DES and follow lesion preparation and stent deployment according to the Instructions per use (IFU) and institutional practices. The DES should be sized per IFU with respect to the vessel RVD. The use of IVUS or OCT is encouraged to guide optimal stent placement and assess final results. After DES deployment, additional balloon inflations should be performed as needed to obtain \< 30% residual diameter stenosis and resolve proximal or distal edge dissections greater than or equal to NHLBI grade B.
Dispositif PCI with SELUTION SLR DCB
After target lesion pre-dilatation and preparation , a SELUTION SLR 014 PTCA DEB study device should be selected with nominal diameter equal to the RVD of the target lesion (1:1 ratio) and length that allows approximately 2.00 mm longer than the proximal and distal edges of the target lesion (defined as the proximal and distal extent of predilation). If IVUS is performed to assess RVD, and DEB upsizing is deemed clinically necessary for optimal results, a maximum nominal DEB diameter of 3.0 mm is permitted. The SELUTION SLR 014 PTCA DEB should then be delivered, positioned in and deployed per instructions per use. The balloon should be inflated for 60 seconds provided that the patient can tolerate this duration. The minimum inflation time is 30 seconds.

Critères de jugement

Critère de jugement principal
Target lesion failure (TLF)
Target lesion failure (TLF) is defined as the composite of cardiac death, target-vessel myocardial infarction (MI) or clinically-driven target lesion revascularization (TLR) at 12 months. MI includes spontaneous (Type 1) MI using the 4th Universal Definition of Myocardial Infarction (UDMI) and peri-procedural MI using the Society for Cardiac Angiography and Intervention (SCAI) definition.
Délai 12 months
Critère de jugement principal
PK Sub-study Primary Endpoint 1
PK parameters of C(max)
Délai 6 months
Critère de jugement principal
PK Sub-study Primary Endpoint 2
PK parameters of T(max)
Délai 6 months
Critère de jugement principal
PK Sub-study Primary Endpoint 3
PK parameters of AUC(last)
Délai 6 months
Critère de jugement principal
PK Sub-study Primary Endpoint 4
PK parameters of MRT(last)
Délai 6 months
Critère de jugement secondaire
Secondary Endpoint 1
Composite of all-cause mortality, target vessel MI or clinically driven target lesion revascularization
Délai 12 months
Critère de jugement secondaire
Secondary Endpoint 2
Lesion success, defined as attainment of \< 30% residual stenosis of target lesion using any percutaneous method
Délai Up to 7 days
Critère de jugement secondaire
Secondary Endpoint 3
Procedure success, defined as attainment of \< 30% residual stenosis of the target lesion using the assigned study device only without the occurrence of in-hospital major adverse cardiac events (MACE), composite of all-cause death, MI or any clinically-driven TLR.
Délai Up to 7 days
Critère de jugement secondaire
Secondary Endpoint 4
Composite safety endpoint, defined as the patient-oriented composite of any death, any MI (spontaneous or peri-procedural), or any repeat revascularization.
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 5
All-Cause Mortality
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 6
Cardiovascular Mortality
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 7
MI (spontaneous MI using the 4th UDMI, peri-procedural MI using SCAI and Academic Research Consortium \[ARC\]-2 definitions)
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 8
Clinically-driven TLR
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 9
all TLR
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 10
Clinically-driven Target Vessel Revascularization (TVR)
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 11
all TVR
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 12
Non-target lesion revascularization
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 13
TLF
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 14
Target vessel failure (TVF), defined as a composite of: cardiac death, target vessel MI (spontaneous or peri-procedural) and any clinically-driven TVR
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 15
Stent or target lesion segment thrombosis (definite or probable) according to the ARC criteria for acute, subacute, late, very late and cumulative stent thrombosis
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Critère de jugement secondaire
Secondary Endpoint 16
Bleeding Academic Research Consortium (BARC) class 2-5
Délai 12 months
Critère de jugement secondaire
Secondary Endpoint 17
Net adverse clinical events, defined as death, MI (spontaneous or peri-procedural), TVR, stent/target lesion segment thrombosis or bleeding (BARC types 2-5, assessed to 12 months)
Délai Up to 7 days and at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Autre critère de jugement
PK Sub-Study Secondary Endpoint 5
If calculations are valid, additional PK parameter of half-life.
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 6
Dose normalized C(max) will be considered if appropriate.
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 7
Dose normalized AUC will be considered if appropriate.
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 1
If calculations are valid, additional PK parameter of AUC(inf).
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 2
If calculations are valid, additional PK parameter of Cl.
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 3
If calculations are valid, additional PK parameter of Vz.
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 4
If calculations are valid, additional PK parameter of Vss.
Délai 6 months
Autre critère de jugement
PK Sub-Study Secondary Endpoint 8
Device success, defined as attainment of ≤ 30% residual stenosis of the target lesion using the assigned device only
Délai 6 months

Dates

Dates
Date de début	20 octobre 2023 (réelle)
Achèvement principal	1 juin 2027 (estimée)
Achèvement	1 juin 2031 (estimée)
Première publication	14 juillet 2023 (réelle)
Dernière mise à jour	16 juillet 2026
Résultats publiés	Non précisé dans la fiche du registre
Statut vérifié pour la dernière fois	juillet 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

68 sites sont en recrutement

Germany

Germany
Établissement	Ville	Statut
Universitäts-Herzzentrum Freiburg	Bad Krozingen	En recrutement
UKB Berlin	Berlin	En recrutement
Herzzentrum Dresden	Dresden	En recrutement
MediClin Herzzentrum Lahr	Lahr	En recrutement

United States

United States
Établissement	Ville	État ou région	Statut
Hendrick Health	Abilene	Texas	En recrutement
Atlanta VA	Atlanta	Georgia	En recrutement
Piedmont Heart Institute	Atlanta	Georgia	En recrutement
Emory	Atlanta	Georgia	En recrutement
HCA Florida JFK	Atlantis	Florida	Retiré
University of Maryland	Baltimore	Maryland	En recrutement
Johns Hopkins	Baltimore	Maryland	Retiré
Beth Israel Deaconess	Boston	Massachusetts	En recrutement
Brigham & Women's	Boston	Massachusetts	En recrutement
Mass General	Boston	Massachusetts	En recrutement
Manatee Memorial	Bradenton	Florida	En recrutement
CAMC	Charleston	West Virginia	En recrutement
University of Nebraska	Chattanooga	Tennessee	En recrutement
CHI Memorial	Chattanooga	Tennessee	En recrutement
CISD Sharp Chula Vista	Chula Vista	California	En recrutement
The Lindner Research Center at Christ	Cincinnati	Ohio	En recrutement
Mease Countryside Hospital	Clearwater	Florida	En recrutement
UH Cleveland	Cleveland	Ohio	En recrutement
Baylor Scott and White - Dallas	Dallas	Texas	En recrutement
Texas Health	Dallas	Texas	En recrutement
Hamilton Medical Center	Dalton	Georgia	En recrutement
Advocate Good Samaritan Hospital	Downers Grove	Illinois	En recrutement
Englewood Health	Englewood	New Jersey	En recrutement
Medical City of Fort Worth	Fort Worth	Texas	En recrutement
Colorado Heart and Vascular	Golden	Colorado	En recrutement
Penn State Health Hershey & Berks	Hershey	Pennsylvania	En recrutement
Cardiovascular Institute of the South	Houma	Louisiana	En recrutement
University of Iowa Medical Center	Iowa City	Iowa	En recrutement
University of Florida, Jacksonville	Jacksonville	Florida	En recrutement
St. Bernards	Jonesboro	Arkansas	En recrutement
HCA Largo	Largo	Florida	En recrutement
Baptist Health Lexington	Lexington	Kentucky	En recrutement
Cedars Sinai	Los Angeles	California	En recrutement
UPMC Pinnacle	Mechanicsburg	Pennsylvania	En recrutement
Advocate Aurora St. Luke's	Milwaukee	Wisconsin	En recrutement
Minneapolis Heart Institute	Minneapolis	Minnesota	En recrutement
Minneapolis VA Medical Center	Minneapolis	Minnesota	En recrutement
Intermountain Health - Salt Lake City	Murray	Utah	En recrutement
HCA Centennial	Nashville	Tennessee	En recrutement
Yale New Haven Hospital	New Haven	Connecticut	En recrutement
Icahn School of Medicine at Mount Sinai	New York	New York	En recrutement
Advocate Christ Medical Center	Oak Lawn	Illinois	En recrutement
Oklahoma Heart	Oklahoma City	Oklahoma	En recrutement
University of Nebraska	Omaha	Nebraska	En recrutement
AdventHealth Orlando	Orlando	Florida	En recrutement
HCA Overland Park	Overland Park	Missouri	En recrutement

20 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05946629