Drug-coating Balloon Treatment in Coronary Artery Disease (ULTIMATE-DCB)

Nanjing Medical University

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: DCB treatment

Study type: Observational

Funder types: Other

Identifiers

NCT04255563

KY20200110-03

Details and patient eligibility

About

Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

Full description

This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.

All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suitable for DCB treatment

Exclusion criteria

• Pregnancy
• Contraindications to contrast media, antiplatelet therapy, or paclitaxel
• Expected life less than 12 months
• Cardiac shock

Trial design

3,000 participants in 1 patient group

DCB treatment

Description:

DCB (Sequent® Please) treatment will be performed for suitable patients with CAD.

Treatment:

Device: DCB treatment