A prospective, open-label, single-centre, randomized study to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents

A prospective, open-label, single-centre, randomized study to evaluate coronary microcirculation in de-novo lesions treated with drug-coated balloons or drug-eluting stents - NEO D5 study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052443

Enrollment

Registered

2023-10-10

Start date

2023-10-09

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

All lesions were pre-dilated using a regular balloon. If a good angiographic result was obtained, patients were randomly assigned to one of the treatment strategies with drug-coated balloon and drug-e

s discretion.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with stable or unstable angina or documented silent ischemia with de novo coronary lesions scheduled to undergo PCI. The inclusion criteria were lesions with a reference vessel diameter between 2.0mm-3.0mm and a lesion length of = or <25mm.

Exclusion criteria

Exclusion criteria: (1) left ventricular ejection fraction <30% (2) known renal failure (creatinine >2mg/dl) (3) acute myocardial infarction within the previous 48 hours (4) history of severe valvular heart disease or hypertrophic cardiomyopathy (5) previous intervention to the same vessel (6) life expectancy <1 year (7) inappropriate lesion for assessment of microcirculation (i.e., left main lesions, ostial lesions, heavily calcified lesions, thrombotic lesions)

Design outcomes

Primary

Measure	Time frame
The status of the coronary microcirculation before and after treatment and at follow-up angiography	—

Secondary

Measure	Time frame
Indices of Coronary Physiology before and after treatment and at follow-up angiography Restenosis and late lumen loss at follow-up angiography Major adverse cardiac events (all-cause death, myocardial infarction and target lesion revascularization) Canadian Cardiovascular Society grading of angina pectoris after treatmen	—

Countries

Japan

Contacts

Public ContactTsutomu Kawai

Osaka General Medical Center Division of cardiology

riverclose0604@yahoo.co.jp06-6692-1201

Outcome results

None listed

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