A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease

A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease - A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients withsmall vessel disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026760

Enrollment

135

Registered

2017-03-29

Start date

2009-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease

Interventions

Paclitaxel-coated balloon Plain balloon

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stable or unstable angina or asymptomatic myocardial ischemia Patients who met the treatment criteria for PCI RVD 2.0mm or larger and <2.75 mm with lesions length <22mm Stenosis of the native coronary artery >50% and <100%

Exclusion criteria

Exclusion criteria: Acute myocardial infarction within 72 hour after onset; acute cardiac failure; pregnancy or lactation; renal dysfunction (serum creatinine >1.5 mg/dl); low left ventricular function (left ventricular ejection fraction <30%) Contraindications or known intolerance to antiplatelet agents, paclitaxel, or contrast agents Lesions in the left main branch; patients meeting the criteria for coronary artery bypass graft (CABG); lesions 2mm or shorter from a bifurcation; multiple lesions in a single branch; patients with highly calcified lesions that were difficult to dilate with a balloon; high-grade bend lesions 90% or more; Previously undergone placement of a paclitaxel-eluting stent or had undergone DES placement within the preceding 24 weeks

Design outcomes

Primary

Measure	Time frame
Target vessel failure	—

Secondary

Measure	Time frame
Procedural success Clinical success MACE TLR Restenosis Late lumen loss	—

Countries

Japan

Contacts

Public ContactNoriko Fujita

Kyoto Katsura hospital Clinical reserch center

noriko.fujita@katsura.com075-391-5811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026