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Balloon battle: which coated catheter wins for tiny heart arteries?

NCT ID NCT04058990

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This trial tests two types of drug-coated balloon catheters to treat small, newly blocked heart arteries. About 180 adults with stable or unstable angina will be randomly assigned to receive one of the two devices during a standard angioplasty procedure. The goal is to see which balloon better keeps the artery open and reduces the chance of future heart problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paclitaxel-coated balloon catheter
What this could lead to
If successful, this could provide a better treatment option for people with small vessel coronary artery disease, potentially reducing the need for stents or repeat procedures.
What could go wrong
This is a relatively small trial (180 participants) and compares two existing devices, so major breakthroughs are unlikely. There is a risk of heart attack or need for repeat procedures, as with any angioplasty.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

180 people

The number who actually took part.

Started

Dec 2019

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subject must be at least 20 years of age. 2. Subject understands the trial requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. 3. Subject is eligible for percutaneous coronary intervention (PCI). 4. 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). * Stenosis that is confirmed a cause of functional ischemia with any test. 5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG). 6. Subject is willing to comply with all protocol-required follow-up evaluation. 7. Patients undergoing first or second treatment for ISR lesions for the non-randomized ISR substudy. 8. 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. 9. 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.). Exclusion Criteria: 1. Subject has had an acute myocardial infarction within 72 hours prior to the index procedure. 2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina. 3. Subject has severe left ventricular dysfunction with ejection fraction \<30%. 4. Subject has received an organ transplant or is on a waiting list for an organ transplant. 5. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure. 6. Subject has renal failure with a serum creatinine of \> 2.0mg/dL or who is receiving dialysis or chronic immunosuppressant therapy. 7. 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. 8. Planned PCI (including staged procedures) or CABG after the index procedure. 9. Subject previously treated at any time with intravascular brachytherapy. 10. 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). 11. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3. 12. Subject has a white blood cell (WBC) count \< 3,000 cells/mm3. 13. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis. 14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months. 16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding. 17. Target vessel has been treated with Paclitaxel Eluting Stent or Balloon prior to the index procedure. 18. Target vessel has been treated with any type of PCI within 6 months prior to the index procedure. 19. Target vessel requires the use of adjunctive primary treatment modalities immediately prior to investigational device's treatment. 20. Non-target vessel has been treated with any type of PCI within 24 hours prior to the index procedure. 21. Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint. 22. Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure. 23. Subject with known intention to procreate within 6 months after the index procedure. 24. Subject is a woman who is pregnant or nursing. 25. 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.). 26. 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. 27. Subject has unprotected left main coronary artery disease (\>50% diameter stenosis). 28. Thrombus, or possible thrombus, present in the target vessel. 29. Subject with known coronary artery spasm.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Japan Labour Health and Welfare Organization Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510, Japan

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Kyoto-Katsura Hospital

    Kyoto, Kyoto, 615-8256, Japan

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki, 880-0834, Japan

  • Osaka Saiseikai Nakatsu Hospital

    Kita, Osaka, 530-0012, Japan

  • Saiseikai Yokohama-City Eastern Hospital

    Yokohama, Kanagawa, 230-8765, Japan

  • Sakurabashi Watanabe Advanced Healthcare Hospital

    Osaka, Osaka, 530-0001, Japan

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido, 065-0033, Japan

  • Sendai Kousei Hospital

    Sendai, Miyagi, 980-0873, Japan

  • Shonan Kamakura General Hospital

    Ōfuna, Kanagawa, 247-8533, Japan

  • Showa Medical University Hospital

    Shinagawa-Ku, Tokyo, 142-8666, Japan

  • Teikyo University Hospital

    tabashi City, Tokyo, 173-8606, Japan

  • Toho University Ohashi Medical Center

    Meguro City, Tokyo, 153-8515, Japan

  • Tokyo Women's Medical University Hospital

    Shinjuku-Ku, Tokyo, 162-8666, Japan

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