NCT01539603

Comparison of Drug Eluting Balloon and Drug Eluting Stent

Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).

Detailed description

A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis. We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.

Conditions

• Coronary Artery Disease
• Stable Angina
• Unstable Angina
• NSTEMI

Interventions

Type	Name	Description
DEVICE	Drug eluting balloon + Bare metal stent	PCI using Sequent Please and then Coroflex Blue
DEVICE	drug eluting stent (Zotarolimus-eluting stent)	conventional PCI using Endeavor Integrity

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2012-02-27
• Last updated: 2015-06-12

Locations

1 site across 1 country: South Korea