Comparison of Drug Eluting Balloon and Drug Eluting Stent (DEBfirst)

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease; Unstable Angina; Stable Angina; NSTEMI

Treatments: Device: Drug eluting balloon + Bare metal stent; Device: drug eluting stent (Zotarolimus-eluting stent)

Study type: Interventional

Funder types: Other

Identifiers

NCT01539603

E-1104/061-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• De novo lesion
• 2.5mm =< Reference diameter =< 4mm
• Lesion length =< 28mm
• Type A, B1/B2 lesion

Exclusion criteria

• ST-segment elevation MI
• Reference diameter < 2.5mm or > 4mm
• Bifurcation lesion
• Type C lesion
• history of AMI or stroke within 1 year F. chronic renal disease (Cr > 2mg/dL)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

DEB-BMS

Experimental group

Description:

Drug eluting balloon + Bare metal stent

Treatment:

Device: Drug eluting balloon + Bare metal stent

Drug eluting stent

Active Comparator group

Description:

conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent)

Treatment:

Device: drug eluting stent (Zotarolimus-eluting stent)