Comparison of Drug Eluting Balloon and Drug Eluting Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)

NCT04937803

Drug-Coated Balloon De Novo Stenosis Acute Coronary Syndromes +4 more

COMPLETED NA

Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction

NCT06742125

ST-elevation Myocardial Infarction (STEMI)

RECRUITING NA

Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

NCT04072081

Acute Myocardial Infarction

UNKNOWN NA

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease

NCT05846893

Coronary Artery Disease Myocardial Ischemia Acute Coronary Syndrome +2 more

RECRUITING NA

DEB Versus 2nd Generation DES in Patients With In-Scaffold Restenosis of Bioresorbable Vascular Scaffold

NCT03074305

Coronary Artery Disease Coronary Restenosis

WITHDRAWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Stable Angina Unstable Angina NSTEMI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DEB-BMS

Drug eluting balloon + Bare metal stent

Group Type EXPERIMENTAL

Drug eluting balloon + Bare metal stent

Intervention Type DEVICE

PCI using Sequent Please and then Coroflex Blue

Drug eluting stent

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

Group Type ACTIVE_COMPARATOR

drug eluting stent (Zotarolimus-eluting stent)

Intervention Type DEVICE

conventional PCI using Endeavor Integrity

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drug eluting balloon + Bare metal stent

PCI using Sequent Please and then Coroflex Blue

Intervention Type DEVICE

drug eluting stent (Zotarolimus-eluting stent)

conventional PCI using Endeavor Integrity

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sequent Please (B.Braun, drug eluting balloon) Coroflex Blue (B.Braun, bare metal stent) Endeavor integrity Zotarolimus-eluting stent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No