The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent

The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent - The degree of endothelial dysfunction caused by treatment of de novo coronary lesion with drug-coated balloon as compared to drug-eluting stent (D5 study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032152

Enrollment

Registered

2018-04-09

Start date

2018-04-09

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) known hypersensitivity or contraindication to the required medication (5) history of vasospastic angina (6) life expectancy <1 year (7) previous intervention to the same vessel

Design outcomes

Primary

Measure	Time frame
The coronary vasoreactivity (the change in luminal diameter of beginning 5 mm and ending 15 mm distal to the end of the treated segment) in response to acetylcholine infusion into the coronary artery at follow-up angiography	—

Secondary

Measure	Time frame
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 treatment	—

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