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

NCT ID: NCT04647253

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2027-09-30

Brief Summary

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.

Conditions

In-Stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

AGENT DCB

Intervention Type: DEVICE

Drug coated PTCA balloon catheter

Commercially available, PTCA Dilation Catheter

Group Type: ACTIVE_COMPARATOR

PTCA balloon catheter

Intervention Type: DEVICE

PTCA balloon catheter

Interventions

AGENT DCB

Drug coated PTCA balloon catheter

Intervention Type: DEVICE

PTCA balloon catheter

PTCA balloon catheter

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.

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.

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Carondelet Medical Group St. Mary's Hospital

Tucson, Arizona, United States

University of California San Diego

La Jolla, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

St. Anthony Hospital

Lakewood, Colorado, United States

South Denver Cardiology

Littleton, Colorado, United States

Tallahassee Memorial Hospital

Tallahassee, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northside Hospital

Lawrenceville, Georgia, United States

Wellstar Kennestone Hospital

Marietta, Georgia, United States

Evanston Hospital

Evanston, Illinois, United States

Overland Park Regional Medical Center

Overland Park, Kansas, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Regions Hospital

Saint Paul, Minnesota, United States

St. Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Bergan Cardiology

Omaha, Nebraska, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Wake Medical Center

Raleigh, North Carolina, United States

Lindner Center for Research and Education at Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

UPMC Pinnacle Health

Wormleysburg, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Methodist North Hospital

Memphis, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Heart Hospital of Austin

Austin, Texas, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 34314727 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38460161 (View on PubMed)

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 19:e043053. doi: 10.1161/JAHA.125.043053. Online ahead of print.

Reference Type: DERIVED

PMID: 41553096 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 41297981 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40803784 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

S2358

Identifier Type: -

Identifier Source: org_study_id