Un essai clinique pour évaluer le cathéter à ballonnet ACTP revêtu de paclitaxel pour le traitement des sujets atteints de resténose intra-stent (ISR) (AGENT IDE)
29 octobre 2026 mis à jour par: Boston Scientific Corporation
AGENT IDE : Un essai prospectif, randomisé (2:1) multicentrique pour évaluer l'innocuité et l'efficacité du cathéter à ballonnet ACTP revêtu de paclitaxel AgentTM pour le traitement des sujets atteints de resténose intra-stent (ISR)
AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
600
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, États-Unis, 85745
- Carondelet Medical Group St. Mary's Hospital
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California
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La Jolla, California, États-Unis, 92037
- University of California San Diego
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Los Angeles, California, États-Unis, 90048
- Cedars Sinai Medical Center
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San Francisco, California, États-Unis, 94121
- San Francisco Veterans Affairs Medical Center
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Stanford, California, États-Unis, 94305
- Stanford University Medical Center
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Colorado
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Lakewood, Colorado, États-Unis, 80216
- St. Anthony Hospital
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Littleton, Colorado, États-Unis, 80210
- South Denver Cardiology
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Florida
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Tallahassee, Florida, États-Unis, 32308
- Tallahassee Memorial Hospital
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University Hospital
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Lawrenceville, Georgia, États-Unis, 30046
- Northside Hospital
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Marietta, Georgia, États-Unis, 30060
- Wellstar Kennestone Hospital
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Illinois
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Evanston, Illinois, États-Unis, 60201
- Evanston Hospital
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Kansas
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Overland Park, Kansas, États-Unis, 66211
- Overland Park Regional Medical Center
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Medical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, États-Unis, 02111
- Tufts Medical Center
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Henry Ford Hospital
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Minnesota
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Saint Paul, Minnesota, États-Unis, 55101
- Regions Hospital
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Missouri
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Kansas City, Missouri, États-Unis, 64111
- St. Luke's Hospital of Kansas City
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Nebraska
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Omaha, Nebraska, États-Unis, 68124
- Bergan Cardiology
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New Jersey
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Neptune City, New Jersey, États-Unis, 07753
- Jersey Shore University Medical Center
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New York
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New York, New York, États-Unis, 10032
- Columbia University Medical Center
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New York, New York, États-Unis, 10467
- Montefiore Medical Center
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Roslyn, New York, États-Unis, 11576
- St. Francis Hospital
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North Carolina
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Raleigh, North Carolina, États-Unis, 27610
- Wake Medical Center
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Lindner Center for Research and Education at Christ Hospital
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Wormleysburg, Pennsylvania, États-Unis, 17053
- UPMC Pinnacle Health
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Rhode Island
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Providence, Rhode Island, États-Unis, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, États-Unis, 38104
- Methodist North Hospital
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Nashville, Tennessee, États-Unis, 37203
- Centennial Medical Center
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Texas
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Austin, Texas, États-Unis, 78756
- Heart Hospital of Austin
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Dallas, Texas, États-Unis, 75226
- Baylor Heart and Vascular Hospital
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Houston, Texas, États-Unis, 77030
- Houston Methodist Hospital
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Virginia
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Charlottesville, Virginia, États-Unis, 22908
- University of Virginia Medical Center
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Falls Church, Virginia, États-Unis, 22042
- Inova Fairfax Hospital
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Washington
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Seattle, Washington, États-Unis, 98195
- University of Washington
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Clinical Inclusion Criteria
- Subject must be at least 18 years of age
- Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed
- Subject is eligible for percutaneous coronary intervention (PCI)
- Subject is willing to comply with all protocol-required follow-up evaluation
- Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure
Angiographic Inclusion Criteria (visual estimate)
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In-stent restenosis in a lesion previously treated with either a drug-eluting stent or bare metal stent, located in a native coronary artery with a visually estimated reference vessel diameter (RVD) > 2.0 mm and ≤ 4.0 mm.
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Target lesion length must be < 26 mm (by visual estimate) and must be covered by only one balloon.
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Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic patients (>70% and <100% in asymptomatic patients) prior to lesion pre-dilation.
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Target lesion must be successfully pre-dilated.
o Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C. Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be >2
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If a non-target lesion is treated, it must be treated first and must be deemed a success.
- Note: Successful treatment of a non-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
Clinical Exclusion Criteria
- Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months.
- Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
- Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
- Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
- Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.)
- Left ventricular ejection fraction known to be < 25%.
- Subject had PCI or other coronary interventions within the last 30 days.
- Planned PCI or CABG after the index procedure.
- STEMI or QWMI <72h prior to the index procedure.
- Cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support).
- Known allergies against paclitaxel or other components of the used medical devices.
- Known hypersensitivity or contraindication for contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.
- Intolerance to antiplatelet drugs, anticoagulants required for procedure.
- Platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3.
- Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
- Subject has suspected or proven COVID-19 at present or within the past 4 weeks with resolution of symptoms.
Angiographic Exclusion Criteria (visual estimate)
- Target lesion is located within a bifurcation with planned treatment of side branch vessel.
- Target lesion is located within a saphenous vein or arterial graft.
- Thrombus present in the target vessel
- > 50% stenosis of an additional lesion proximal or clinically significant distal (>2.0mm RVD) to the target lesion.
- Patient with unprotected left main coronary artery disease. (>50% diameter stenosis)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Cathéter de dilatation ACTP disponible dans le commerce
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PTCA balloon catheter |
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Expérimental: AGENT DCB
Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). |
Drug coated PTCA balloon catheter |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants With Target Lesion Failure
Délai: 12-month
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The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death |
12-month
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Robert Yeh, MD, Beth Israel Deaconess Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Yeh RW, Bachinsky W, Stoler R, Bateman C, Tremmel JA, Abbott JD, Dohad S, Batchelor W, Underwood P, Allocco DJ, Kirtane AJ. Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis. Am Heart J. 2021 Nov;241:101-107. doi: 10.1016/j.ahj.2021.07.008. Epub 2021 Jul 24.
- Yeh RW, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Bateman C, Krishnaswamy A, Grantham JA, Zidar FJ, Marso SP, Tremmel JA, Grines C, Ahmed MI, Latib A, Tehrani B, Abbott JD, Batchelor W, Underwood P, Allocco DJ, Kirtane AJ; AGENT IDE Investigators. Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1015-1024. doi: 10.1001/jama.2024.1361.
- Kirtane AJ, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Bateman C, Krishnaswamy A, Grantham JA, Zidar FJ, Tremmel JA, Grines C, Ahmed MI, Latib A, Tehrani B, Abbott JD, Batchelor W, Cavalcante R, Yeh RW. Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis. J Am Coll Cardiol. 2025 Aug 19;86(7):502-511. doi: 10.1016/j.jacc.2025.05.062.
- Wen J, Dohad S, Shlofmitz R, Moses J, Bachinsky W, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Neupane S, Croce K, Shunk K, Taylor A, Saybolt MD, Diaz C, Cavalcante R, Yeh RW, Kirtane AJ. Paclitaxel-Coated Balloon for the Treatment of Small Vessel In-Stent Restenosis: A Subgroup Analysis of the AGENT IDE Randomized Trial. JACC Cardiovasc Interv. 2025 Nov 24;18(22):2701-2710. doi: 10.1016/j.jcin.2025.09.032.
- Jamil Y, Kirtane A, Yeh RW, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Krishnaswamy A, Alaswad K, Kimmelstiel C, Reitman A, Cavalcante R, Tehrani BN, Batchelor WB. Paclitaxel-Coated Balloon for Treating In-Stent Restenosis in Racial and Ethnic Minority Patients: A Subanalysis From the AGENT IDE Trial. J Am Heart Assoc. 2026 Jan 20;15(2):e043053. doi: 10.1161/JAHA.125.043053. Epub 2026 Jan 19.
- Abbott JD, Kassis N, Latib A, Shlofmitz RA, Moses JW, Bachinsky WB, Dohad S, Rudick SG, Stoler RC, Jefferson BK, Nicholson WJ, Altman JD, Bateman CT, Krishnaswamy A, Cavalcante R, Yeh RW, Kirtane AJ. Predictors of Target Lesion Failure in Patients With In-Stent Restenosis: Insights From the AGENT IDE Trial. Circ Cardiovasc Interv. 2026 Aug 6:e016289. doi: 10.1161/CIRCINTERVENTIONS.125.016289. Online ahead of print.
- Tehrani BN, Vavilin I, Shlofmitz R, Moses J, Bachinsky W, Dohad S, Rudick S, Stoler R, Jefferson BK, Nicholson W, Altman J, Bateman C, Tremmel JA, Abbott JD, Batchelor W, Cavalcante R, Yeh RW, Kirtane AJ. Influence of Chronic Kidney Disease on Outcomes After Paclitaxel-Coated Balloon Angioplasty for Coronary In-Stent Restenosis. Circ Cardiovasc Interv. 2026 Sep 17:e016978. doi: 10.1161/CIRCINTERVENTIONS.126.016978. Online ahead of print.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
11 mai 2021
Achèvement primaire (Réel)
2 octobre 2023
Achèvement de l'étude (Estimé)
1 septembre 2027
Dates d'inscription aux études
Première soumission
23 novembre 2020
Première soumission répondant aux critères de contrôle qualité
23 novembre 2020
Première publication (Réel)
30 novembre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- S2358
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .