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

NCT ID NCT04058990

Completed Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

CORONARY ARTERY DISEASE

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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