En klinisk prövning för att utvärdera den paklitaxelbelagda PTCA-ballongkatetern för behandling av patienter med in-stent-restenos (ISR) (AGENT IDE)
29 oktober 2026 uppdaterad av: Boston Scientific Corporation
AGENT IDE: A Prospective, Randomized (2:1), Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
600
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Förenta staterna, 85745
- Carondelet Medical Group St. Mary's Hospital
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California
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La Jolla, California, Förenta staterna, 92037
- University of California San Diego
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Los Angeles, California, Förenta staterna, 90048
- Cedars Sinai Medical Center
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San Francisco, California, Förenta staterna, 94121
- San Francisco Veterans Affairs Medical Center
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Stanford, California, Förenta staterna, 94305
- Stanford University Medical Center
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Colorado
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Lakewood, Colorado, Förenta staterna, 80216
- St. Anthony Hospital
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Littleton, Colorado, Förenta staterna, 80210
- South Denver Cardiology
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Florida
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Tallahassee, Florida, Förenta staterna, 32308
- Tallahassee Memorial Hospital
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital
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Lawrenceville, Georgia, Förenta staterna, 30046
- Northside Hospital
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Marietta, Georgia, Förenta staterna, 30060
- Wellstar Kennestone Hospital
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Illinois
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Evanston, Illinois, Förenta staterna, 60201
- Evanston Hospital
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Kansas
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Overland Park, Kansas, Förenta staterna, 66211
- Overland Park Regional Medical Center
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70121
- Ochsner Medical Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Förenta staterna, 02111
- Tufts Medical Center
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
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Minnesota
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Missouri
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Kansas City, Missouri, Förenta staterna, 64111
- St. Luke's Hospital of Kansas City
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68124
- Bergan Cardiology
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New Jersey
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Neptune City, New Jersey, Förenta staterna, 07753
- Jersey Shore University Medical Center
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University Medical Center
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New York, New York, Förenta staterna, 10467
- Montefiore Medical Center
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Roslyn, New York, Förenta staterna, 11576
- St. Francis Hospital
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North Carolina
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Raleigh, North Carolina, Förenta staterna, 27610
- Wake Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45219
- Lindner Center for Research and Education at Christ Hospital
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Wormleysburg, Pennsylvania, Förenta staterna, 17053
- UPMC Pinnacle Health
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02903
- Rhode Island Hospital
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38104
- Methodist North Hospital
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Nashville, Tennessee, Förenta staterna, 37203
- Centennial Medical Center
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Texas
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Austin, Texas, Förenta staterna, 78756
- Heart Hospital of Austin
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Dallas, Texas, Förenta staterna, 75226
- Baylor Heart and Vascular Hospital
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Houston, Texas, Förenta staterna, 77030
- Houston Methodist Hospital
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Medical Center
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Falls Church, Virginia, Förenta staterna, 22042
- Inova Fairfax Hospital
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Washington
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Seattle, Washington, Förenta staterna, 98195
- University of Washington
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Kommersiellt tillgänglig, PTCA-dilatationskateter
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PTCA balloon catheter |
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Experimentell: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants With Target Lesion Failure
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Robert Yeh, MD, Beth Israel Deaconess Medical Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
11 maj 2021
Primärt slutförande (Faktisk)
2 oktober 2023
Avslutad studie (Beräknad)
1 september 2027
Studieregistreringsdatum
Först inskickad
23 november 2020
Först inskickad som uppfyllde QC-kriterierna
23 november 2020
Första postat (Faktisk)
30 november 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 november 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 oktober 2026
Senast verifierad
1 oktober 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- S2358
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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