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Coronary Artery DiseaseNCT04058990

Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)

A study testing Device: Paclitaxel-Coated PTCA Balloon Catheter and SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel in people with Coronary Artery Disease, run by Boston Scientific Corporation at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Device: Paclitaxel-Coated PTCA Balloon Catheter and SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
14 sitesJapan
Study dates
12 Dec 2019to 7 Jul 2026
Phase
Interventional
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be at least 20 years of age.
  • Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
  • Subject is eligible for percutaneous coronary intervention (PCI).
  • Subject has documented stable angina pectoris or unstable angina pectoris. If subject has documented stable angina pectoris, one of the following criteria meet.
  • ≥90% diameter stenosis.
  • Stenosis that is considered a cause of stable effort angina (Only when it's without confirmation of significant stenosis).
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  • Stenosis that is confirmed a cause of functional ischemia with any test.
  • Subject is an acceptable candidate for coronary artery bypass grafting (CABG).
  • Subject is willing to comply with all protocol-required follow-up evaluation.
  • Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy.
  • The target lesion meets all following criteria.
  • Target lesion length must measure (by visual estimate) ≤28 mm.
  • Target lesion must be a visually estimated reference vessel diameter (RVD) ≥2.00mm and <3.00 mm (This applys for SV trial. For ISR substudy: RVD ≥2.00mm and ≤4.00 mm.).
  • Target lesion must be a de novo lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100% (This applys for SV trial. For ISR substudy: Target lesion for ISR must be in-stent restenosis of a previously-treated lesion located in a native coronary artery with visually estimated stenosis ≥75% and <100%.).
  • Coronary anatomy is likely to allow delivery of an investigational device to the lesions.
  • Target lesion must be successfully pre-dilated.
  • Planned treatment of 2 coronary artery lesions in 2 vessels may be treated (For SV trial, up to two lesions per vessel can be treated. For ISR substudy, single lesion per vessel can be treated.).

Who cannot join

  • Subject has had an acute myocardial infarction within 72 hours prior to the index procedure.
  • Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina.
  • Subject has severe left ventricular dysfunction with ejection fraction <30%.
  • Subject has received an organ transplant or is on a waiting list for an organ transplant.
  • Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure.
  • Subject has renal failure with a serum creatinine of > 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy.
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  • Subjects has one of the following.
  • Not expected to live for the duration of the study (1 year) by investigator's discretion due to other serious medical illness.
  • Current problems with substance abuse.
  • Planned procedure that may cause non-compliance with the protocol or confound data interpretation.
  • Planned PCI (including staged procedures) or CABG after the index procedure.
  • Subject previously treated at any time with intravascular brachytherapy.
  • Subject has a known allergy to contrast and/or the investigational device or protocol-required concomitant medications, iopromide, raw materials of Agent DCB and SeQuent Please DCB, P2Y12 inhibitor or aspirin).
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  • Subject has a white blood cell (WBC) count < 3,000 cells/mm3.
  • Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
  • Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
  • Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
  • Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure.
  • Target vessel has been treated with any type of PCI within 6 months prior to the index procedure.
  • Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment.
  • Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure.
  • Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint.
  • Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
  • Subject with known intention to procreate within 6 months after the index procedure.
  • Subject is a woman who is pregnant or nursing.
  • Target lesion meets any of the following criteria:
  • Left main location.
  • Located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate.
  • > 50% stenosis of an additional lesion proximal or distal to the target lesion (by visual estimate).
  • Located within a saphenous vein graft or an arterial graft.
  • Will be accessed via a saphenous vein graft or an arterial graft.
  • Involves a complex bifurcation (e.g., bifurcations requiring treatment with more than 1 stent).
  • TIMI flow 0 (total occlusion) prior to wire crossing.
  • Excessive tortuosity proximal to or within the lesion.
  • Extreme angulation proximal to or within the lesion.
  • Target lesion and/or target vessel proximal to the lesion is severely calcified by visual estimate to expect sub-optimal balloon expansion.
  • Target lesion and/or target vessel adjacent to the target lesion presents with dissection or aneurysm by visual estimate.
  • Restenosis from previous intervention (This is applicable only to SV trial.).
  • PCI within 10 mm proximal or distal to the target lesion (by visual estimate) at any time prior to the index procedure （This is applicable only to SV trial.）.
  • Planned treatment of a single lesion with more than 1 investigational device.
  • In-stent restenosis due to stent fracture or recoil (This is applicable only to ISR substudy.).
  • Non-target lesion to be treated during the index procedure meets any of the following criteria:
  • Located in the target vessel (This is applicable only to ISR substudy.).
  • Located within a bypass graft (venous or arterial).
  • Left main location.
  • Chronic total occlusion.
  • Involves a complex bifurcation.
  • Located within 15 mm of the proximal or distal shoulder of the target lesion by visual estimate in the case of the same vessel with a target lesion for SV trial.
  • Subject has unprotected left main coronary artery disease (>50% diameter stenosis).
  • Thrombus, or possible thrombus, present in the target vessel.
  • Subject with known coronary artery spasm.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Japan Labour Health and Welfare Organization Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510

  • Osaka Saiseikai Nakatsu Hospital

    Kita, Osaka, 530-0012

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto, 615-8256

  • Toho University Ohashi Medical Center

    Meguro City, Tokyo, 153-8515

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, 880-0834

  • Shonan Kamakura General Hospital

    Ōfuna, Kanagawa, 247-8533

  • Sakurabashi Watanabe Advanced Healthcare Hospital

    Osaka, Osaka, 530-0001

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido, 065-0033

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873

  • Showa Medical University Hospital

    Shinagawa-Ku, Tokyo, 142-8666

  • Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo, 162-8666

  • Teikyo University Hospital

    tabashi City, Tokyo, 173-8606

  • Saiseikai Yokohama-City Eastern Hospital

    Yokohama, Kanagawa, 230-8765

Other trials in Japan

About this study

Official title: A 2:1 Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

Read the detailed description

Primary objective is to evaluate the safety and effectiveness of the Agent ™ Paclitaxel-Coated PTCA Balloon Catheter for the treatment of Japanese subjects with a small vessel de novo native atherosclerotic coronary artery lesion or in-stent restenosis (ISR) of a previously treated lesion.

Primary endpoint: Target Lesion Failure (TLF) rate at 6 months post index-procedure. TLF is 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.

Being tested
Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • Device: Paclitaxel-Coated PTCA Balloon CatheterDevice

    Percutaneous Transluminal Coronary Angioplasty

  • SeQuent Please Drug Eluting Balloon Catheter with PaclitaxelDevice

    Percutaneous Transluminal Coronary Angioplasty

Study groups in NCT04058990
Study groupRoleWhat they receive
Agent Paclitaxel-Coated PTCA Balloon CatheterExperimentalTreatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)
Receives: Device: Device: Paclitaxel-Coated PTCA Balloon Catheter
SeQuent Please Drug Eluting Balloon CatheterActive comparatorTreatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)
Receives: Device: SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel

What is being measured

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

  1. Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure)

    TLF is 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: 6 months post procedure

Timeline

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

  1. First posted16 Aug 2019
  2. Study start12 Dec 2019
  3. Primary completion22 Dec 2021
  4. Study completion7 Jul 2026

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04058990
Sponsor's protocol ID
S2313
Status last verified
Jul 2026
First submitted
8 Aug 2019
Last updated
23 Jul 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication. The information and data, obtained from the trial is used without personal identification.

Questions about this trial

What is this clinical trial studying?

A study testing Device: Paclitaxel-Coated PTCA Balloon Catheter and SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel in people with Coronary Artery Disease, run by Boston Scientific Corporation at 14 sites in Japan.

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

Who may be eligible to take part?

The sponsor lists 17 inclusion and 53 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2022). 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?

Percentage of Participants With Events Included in the Primary Endpoint (Target Lesion Failure) (time frame: 6 months post procedure). 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 NCT04058990.

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 23 Jul 2026.

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