AzTrials
AzTrials

In-Stent RestenosisPhase 3AGENT IDENCT04647253

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

A Phase 3 study testing AGENT DCB and PTCA balloon catheter in people with In-Stent Restenosis, run by Boston Scientific Corporation at 40 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
In-Stent Restenosis
What is being tested?
AGENT DCB and PTCA balloon catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
40 sitesUnited States
Study dates
11 May 2021to Sep 2027
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.
  • 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)

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Lindner Center for Research and Education at Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75226

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Evanston Hospital

    Evanston, Illinois, 60201

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • St. Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • University of California San Diego

    La Jolla, California, 92037

  • St. Anthony Hospital

    Lakewood, Colorado, 80216

  • Northside Hospital

    Lawrenceville, Georgia, 30046

  • South Denver Cardiology

    Littleton, Colorado, 80210

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Methodist North Hospital

    Memphis, Tennessee, 38104

  • Centennial Medical Center

    Nashville, Tennessee, 37203

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Columbia University Medical Center

    New York, New York, 10032

  • Montefiore Medical Center

    New York, New York, 10467

  • Bergan Cardiology

    Omaha, Nebraska, 68124

  • Overland Park Regional Medical Center

    Overland Park, Kansas, 66211

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • San Francisco Veterans Affairs Medical Center

    San Francisco, California, 94121

  • University of Washington

    Seattle, Washington, 98195

  • Stanford University Medical Center

    Stanford, California, 94305

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Carondelet Medical Group St. Mary's Hospital

    Tucson, Arizona, 85745

  • UPMC Pinnacle Health

    Wormleysburg, Pennsylvania, 17053

Other trials in United States

About this study

Official title: 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.

Being tested
AGENT DCB, PTCA balloon catheter
Keywords
Drug coated balloon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AGENT DCBDevice

    Drug coated PTCA balloon catheter

  • PTCA balloon catheterDevice

    PTCA balloon catheter

Study groups in NCT04647253
Study groupRoleWhat they receive
AGENT DCBExperimentalAgent 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).
Receives: Device: AGENT DCB
Commercially available, PTCA Dilation CatheterActive comparatorNot described
Receives: Device: PTCA balloon catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Target Lesion Failure

    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

    Measured: 12-month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2020
  2. Study start11 May 2021
  3. Primary completion2 Oct 2023
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, Randomized (2:1), Multicenter Trial
Masking
Single blind
Who is masked
Participant
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04647253
Sponsor's protocol ID
S2358
Acronym
AGENT IDE
Status last verified
Oct 2026
First submitted
23 Nov 2020
Last updated
2 Nov 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 34314727

  • 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.

    PubMed 38460161

  • 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.

    PubMed 42751771

  • 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.

    PubMed 42558055

  • 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.

    PubMed 41553096

  • 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.

    PubMed 41297981

  • 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.

    PubMed 40803784

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AGENT DCB and PTCA balloon catheter in people with In-Stent Restenosis, run by Boston Scientific Corporation at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Target Lesion Failure (time frame: 12-month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04647253, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in