Balloon battle: which coated catheter wins for tiny heart arteries?
NCT ID NCT04058990
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
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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
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180 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Jul 2026
- Lead sponsor
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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
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Japan Labour Health and Welfare Organization Kanto Rosai Hospital
Kawasaki, Kanagawa, 211-8510, Japan
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Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
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Kyoto-Katsura Hospital
Kyoto, Kyoto, 615-8256, Japan
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Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-0834, Japan
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Osaka Saiseikai Nakatsu Hospital
Kita, Osaka, 530-0012, Japan
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Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, 230-8765, Japan
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Sakurabashi Watanabe Advanced Healthcare Hospital
Osaka, Osaka, 530-0001, Japan
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Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033, Japan
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Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
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Shonan Kamakura General Hospital
Ōfuna, Kanagawa, 247-8533, Japan
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Showa Medical University Hospital
Shinagawa-Ku, Tokyo, 142-8666, Japan
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Teikyo University Hospital
tabashi City, Tokyo, 173-8606, Japan
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Toho University Ohashi Medical Center
Meguro City, Tokyo, 153-8515, Japan
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Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666, Japan
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