Comparison of Drug Eluting Balloon and Drug Eluting Stent

Coronary Artery Disease Clinical Trial

— DEBfirst  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539603
• Other study ID #: E-1104/061-001
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2012
• Last updated: June 11, 2015
• Start date: April 2011
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• NSTEMI
• Stable Angina
• Unstable Angina

Intervention

Device:
• Drug eluting balloon + Bare metal stent
PCI using Sequent Please and then Coroflex Blue
• drug eluting stent (Zotarolimus-eluting stent)
conventional PCI using Endeavor Integrity

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Universtiy Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-segment late loss	angiographic in-segment late loss measure by QCA program	9 month	No
Secondary	stent thrombosis	any stent thrombosis	9 month	Yes
Secondary	angiographic and procedure success	Angiographic success denotes that residual diameter stenosis is less than 10% without complication such as coronarhy dissection or thrombosis.; Procedural success means that adequate DEB+BMS or DES delivery to the target lesion without geographic miss.	9 month	No
Secondary	MACE	death, MI and TVF	9 month	Yes