A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) (AGENT IDE)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: In-Stent Restenosis
• Intervention / Treatment: Device: AGENT DCB; Device: PTCA balloon catheter

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Carondelet Medical Group St. Mary's Hospital
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • San Francisco, California, United States, 94121
      • San Francisco Veterans Affairs Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Lakewood, Colorado, United States, 80216
      • St. Anthony Hospital
    • Littleton, Colorado, United States, 80210
      • South Denver Cardiology
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Lawrenceville, Georgia, United States, 30046
      • Northside Hospital
    • Marietta, Georgia, United States, 30060
      • WellStar Kennestone Hospital
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Hospital
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Overland Park Regional Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital of Kansas City
  • Nebraska
    • Omaha, Nebraska, United States, 68124
      • Bergan Cardiology
  • New Jersey
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10467
      • Montefiore Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Wake Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Center for Research and Education at Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17053
      • UPMC Pinnacle Health
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist North Hospital
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

• 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.
• Target lesion length must be < 26 mm (by visual estimate) and must be covered by only one balloon.
• Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic patients (>70% and <100% in asymptomatic patients) prior to lesion pre-dilation.

• 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

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: AGENT DCB; Drug coated PTCA balloon catheter
Active Comparator: Commercially available, PTCA Dilation Catheter	Device: PTCA balloon catheter; PTCA balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure Rate	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Robert Yeh, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): October 2, 2023
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Drug coated balloon
• Other Study ID Numbers: S2358

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes