Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment

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

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2019-02-28

Brief Summary

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

This is a prospective, multicentre, randomized clinical study of consecutive patients with coronary artery disease in vessels with diameter ≤2.75 mm. Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES). Study population will consist of 240 patients with stable or unstable angina

Related Clinical Trials

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

Drug-Coated Balloon in Combination With New Generation Drug-Eluting Stent for de Novo Diffuse Disease Treatment

NCT03939468

Coronary Artery Disease

UNKNOWN

Comparison of Safety and Efficacy of Coronary Drug-coated Balloon (DCB) Combined With Spot Stenting of Drug-eluting Stent (DES) Versus Second-generation DES for Treating Diffuse Coronary Artery Lesions: a Prospective, Randomized, Controlled Clinical Trial

NCT03589157

Diffuse Coronary Artery Lesions

UNKNOWN NA

Basel Stent Kosten Effektivitäts Trial Drug Eluting Balloons vs. Drug Eluting Stents in Small Vessel Interventions

NCT01574534

Coronary Heart Disease

COMPLETED NA

Pressure-wire Guided PTCA: Drug Eluting Stent Versus Drug Eluting Balloon (WinDEB Study)

NCT01399463

Coronary Artery Disease

UNKNOWN NA

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

Detailed Description

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

Conditions

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

Cardiovascular Diseases

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.

new generation DEB

drug-eluting balloon (DEB)

Group Type OTHER

drug-eluting balloon

Intervention Type DEVICE

Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)

second generation DES

standard therapy with second generation drug-eluting stent (DES)

Group Type OTHER

drug-eluting stent

Intervention Type DEVICE

Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).

Interventions

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

drug-eluting balloon

Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)

Intervention Type DEVICE

drug-eluting stent

Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

1. Age \>18 years.
2. Stable or unstable coronary artery disease.
3. Native coronary artery lesion in vessel with diameter \<2.75 mm.
4. Clinical indication to percutaneous coronary intervention (PCI).

Exclusion Criteria

1. Enrolment in another study with any investigational drug or device.
2. Acute or recent (≤48 hours) myocardial infarction.
3. Creatinine clearance \<50 ml/min.
4. Left ventricle ejection fraction \<30%.
5. Any known allergy, hypersensitivity or intolerance to any drug used during or after the procedure.
6. Heavily calcified and severely tortuous lesions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No