Trial Radar IA | ||
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Lo studio clinico NCT04280029 (SELUTION4ISR) per Restenosi coronarica è attivo, non in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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SELUTION SLR™ 014 In-stent Restenosis (SELUTION4ISR)
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT04280029 (SELUTION4ISR) è uno studio interventistico per Restenosi coronarica, attualmente attivo, non in arruolamento. Avviato il 6 luglio 2020, prevede di arruolare 418 partecipanti. Sotto la guida di M.A. Med Alliance S.A., dovrebbe concludersi entro il 1 agosto 2029. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 agosto 2025.
Sommario breve
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial.
Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.
The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB in all patients.
Descrizione dettagliata
Prospective, multi-center, randomized, single blind, controlled, noninferiority clinical trial will enroll up to 418 randomized subjects (including up to 60 subjects in an angiographic and optical coherence tomography [OCT] sub-study) at up to 80 sites in the United States (US), Canada, Brazil, and Europe (EU). A minimum of 50% of the subjects will be enrolled in the US.
Subjects with previous bare-metal stent (BMS) or DES and qualifying evidence for ISR will be screened per the protocol inclusion and exclusion criteria. Eligible subjects will be randomized 1:1 to treatment with either the SELUTION SLR™ 014 DEB or SOC to include contemporary DES (zotarolimus-eluting stents [ZES] and everolimus-eluting stents [EES] only) or BA. A maximum of 20% of patients randomized to SOC will be treated with BA.
The primary endpoint will be Target Lesion Failure (TLF) at 12-months in the SOC group vs. the SELUTION SLR™ 014 DEB group.
A subset of up to 60 subjects will be enrolled in the angiographic and OCT sub-study and undergo planned angiographic and OCT follow-up within 30 days after completion of the 12-month primary endpoint clinical follow-up/assessment.
Titolo ufficiale
SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects With In-stent Restenosis
Condizioni
Restenosi coronaricaPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- SELUTION4ISR
- SEL-003-2019
Numero NCT
Data di inizio (effettiva)
2020-07-06
Ultimo aggiornamento pubblicato
2025-08-28
Data di completamento (stimata)
2029-08
Arruolamento (previsto)
418
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
In-stent restenosis
Drug Eluting Balloon
Coronary
Drug Eluting Balloon
Coronary
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
SperimentaleSELUTION SLR™ DEB The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus). | SELUTION SLR™ DEB The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with a drug (Sirolimus). |
Comparatore attivoControl Treatment POBA or FDA-approved -limus DES | CONTROLLO POBA or FDA-approved -limus DES |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Target Lesion Failure | The primary safety and efficacy endpoint is TLF at 12 months post-index procedure for SELUTION SLR 014 DEB versus SOC in all patients. TLF is defined as all cardiac death, target vessel myocardial infarction (MI) or clinically driven TLF.
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. | 12 months post-index procedure |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
In-segment minimal luminal diameter (MLD) | The powered secondary endpoint will be in-segment minimal luminal diameter (MLD) at 12 months (after documented completion of 12 months of clinical follow-up) in the angiographic follow-up subset. | at 12 months |
Device success | Attainment of \< 30% residual stenosis of the target lesion using the assigned study device only. | at 12 months |
Lesion Success | Attainment of \< 30% residual stenosis of target lesion using any percutaneous method. | at 12 months |
Procedure Success | 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), a composite of all-cause death, MI or clinically driven TLR. | at 12 months |
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Subject age is ≥ 18 years or minimum legal age as required by local regulations.
- Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
- Subject presents with chronic coronary syndrome (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 percutaneous coronary intervention (PCI) and planned intervention.
- Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus either Clopidogrel, Prasugrel, or Ticagrelor. Note: Subjects who require continued oral anticoagulant therapy my omit aspirin at discretion of investigator.
- Life expectancy >1 year in opinion of investigator.
- Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
Angiographic Inclusion Criteria
- Target lesion is within a native coronary artery or major branch.
- Target lesion is within a previously placed BMS or DES and does not extend further than 5 mm beyond either the proximal or distal edge of the stent.
- Up to two (2) non-target lesions in non-target vessels may be treated, but successful PCI of the non-target lesions must be completed before treatment of the target lesion. Successful treatment is defined as no greater than 30% residual stenosis by visual estimate, no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C, and Thrombolysis in Myocardial Infarction (TIMI) grade flow in the non-target lesion > 2.
- Target lesion is ≤ 26 mm in length.
- Target lesion has diameter stenosis of > 50% and ≤ 99% by visual estimate.
- Reference vessel diameter (RVD) is ≥ 2.00 mm and ≤ 4.50 mm.
- Target lesion must be successfully pre-dilated/pre-treated. Note: Successful pre-dilation/pre-treatment is defined as dilation or pre-treatment that achieves stent expansion of approximately 80% of the distal RVD (at the discretion of the investigator) based on intravascular ultrasound (IVUS)/optical coherence tomography (OCT) and no greater than 30% residual stenosis by visual estimate and no dissection greater than NHLBI type C. TIMI grade flow in the target lesion must be > 2. Note: Atherectomy and cutting balloon are permitted for pre-treatment.
- Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure.
- ST-elevation myocardial infarction (STEMI) within 30 days.
- Planned treatment of additional lesions in the target vessel, or more than two (2) non-target lesions within non-target vessels, during the index procedure.
- Target lesion is located within a bifurcation with planned treatment of side branch vessel.
- Target lesion is the 3rd or greater stent failure (i.e., more than two [2] layers of stent are present at any segment of the target lesion).
- Target vessel had any previous vascular brachytherapy treatment or is planned to undergo brachytherapy at index procedure.
- Previous PCI of the target vessel within 30 days.
- Planned PCI of a non-target vessel, or a non-target lesion in the target vessel, within 30 days of randomization.
- 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 has undergone renal transplantation.
- Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
- History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.
- Subject is pregnant, breast-feeding, or a woman of childbearing potential who is not using appropriate contraceptives to avoid becoming pregnant.
- Documented left ventricular ejection fraction (LVEF) < 25%.
- Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
Angiographic Exclusion Criteria
- Target lesion is a total occlusion or has evidence of thrombus.
- Target lesion involves an unprotected left main.
- Target lesion has > 30% residual stenosis by visual estimate or dissection greater than NHLBI type C after pre-dilation/pre-treatment.
M.A. Med Alliance S.A.- Iqvia Pty Ltd
- Cordis US Corp.
Nessun dato di contatto
48 Centri dello studio in 7 paesi
Cotignola
Maria Cecilia Hospital, Cotignola, Cotignola, 48033, Italy
Milano
Instituto Clinico Humanitas Milan, Milan, Milano, 20089, Italy
Padova
Center Azienda Ospedaliero Universitaria de Padova, Padua, Padova, 35128, Italy
California
Loma Linda University, Loma Linda, California, 92354, United States
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States
Harbor-UCLA Medical Center, Torrance, California, 90502, United States
Colorado
ClinRe 001-001, Thornton, Colorado, 80023, United States
District of Columbia
MedStar Heart Institute, Washington D.C., District of Columbia, 20010, United States
Florida
University of Florida Health, Jacksonville, Florida, 32209, United States
Baptist Cardiac & Vascular Institute, Miami, Florida, 33176, United States
Georgia
Atlanta VA Medical Center, Atlanta, Georgia, 30033, United States
Piedmont Heart Institute, Atlanta, Georgia, 30309, United States
Indiana
Ascension St Vincents Heart Center, Indianapolis, Indiana, 46260, United States
Kansas
Ascension Via Christi, Wichita, Kansas, 67226, United States
Maryland
University of Maryland, Baltimore, Maryland, 21201, United States
Massachusetts
Beth Israel Deaconess Medical Centre, Harvard Medical School, Boston, Massachusetts, 02215, United States
Michigan
Ascension Borgess Heart Institute, Kalamazoo, Michigan, 49048, United States
Beaumont Hospital, Royal Oak, Michigan, 48073, United States
Ascension St John Hospital, Southfield, Michigan, 48075, United States
Minnesota
Minneapolis Heart Institute, Minneapolis, Minnesota, 55407, United States
New Hampshire
Manchester Catholic Medical Center, Manchester, New Hampshire, 03102, United States
New Jersey
Morristown Medical Center, Morristown, New Jersey, 07960, United States
Rutgers, Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08901, United States
New York
Mount Sinai Hospital, New York, New York, 10029, United States
St. Francis Hospital & Heart Center, Roslyn, New York, 11576, United States
North Carolina
Moses H. Cone Memorial Hospital, Greensboro, North Carolina, 27401, United States
NC Heart and Vascular Research, LLC, Raleigh, North Carolina, 27607, United States
Ohio
The Christ Hospital, Cincinnati, Ohio, 45219, United States
Oklahoma
Integris, Oklahoma City, Oklahoma, 73112, United States
Pennsylvania
UPMC Pinnacle Health, Harrisburg, Pennsylvania, 17104, United States
Pennsylvania State University Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States
Rhode Island
Lifespan Cardiovascular Institute, Providence, Rhode Island, 02903, United States
Tennessee
HCA Centennial, Nashville, Tennessee, 37203, United States
Texas
Baylor Scott & White, Dallas, Texas, 75204, United States
Texas Tech University Health Sciences Center, Lubbock, Texas, 79430, United States
Baylor Scott & White, Temple, Texas, 76508, United States
Virginia
HCA Chippenham/VA Cardiovascular Specialists, Richmond, Virginia, 23225, United States
HartCentrum Hasslet, Jessa Ziekenhuis, Hasselt, Belgium
São Paulo
Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, 04012-180, Brazil
Instituto do Coração - São Paulo University, São Paulo, São Paulo, 05403-900, Brazil
Ontario
Hamilton Health Sciences, Hamilton, Ontario, L8N 3Z5, Canada
Dijon
Clinique Valmy, Dijon, Dijon, 21000, France
Massy
Hôpital privé Jacques Cartier, Massy, Massy, 91300, France
Rouen
Clinique Saint Hilaire, Rouen, Rouen, 76000, France
Toulouse
CHU Toulouse Rangueil, Toulouse, Toulouse, 31400, France
AZ
Amsterdam UMC, Academic Medical Centre, Amsterdam, AZ, 1105, Netherlands
CX
UMC Utrecht, Utrecht, CX, 3584, Netherlands
GZ
UMCG, Groningen, GZ, 9718, Netherlands