Drug-Eluting Balloon Registry in Routine Clinical Practice (IRIS DEB)

Seung-Jung Park

Status: Enrolling

Conditions: Coronary Artery Disease; Angioplasty, Balloon

Treatments: Device: Balloon angioplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02038660

AMCCV2013-10

Details and patient eligibility

About

The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow
• Age 20 and more
• Treated with Balloon angioplasty
• Signed informed consent and agreed to follow protocol

Exclusion criteria

• Allergy to paclitaxel, antiplatelet
• History of side effect to heparin, aspirin, thienopyridines
• History of bleeding tendency, coagulation disorder, blood transfusion reaction

Trial design

1,500 participants in 1 patient group

Patients with coronary artery disease

Treatment:

Device: Balloon angioplasty