Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries
NCT ID: NCT01903902
Last Updated: 2013-07-19
Study Results
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.
UNKNOWN
PHASE4
1000 participants
INTERVENTIONAL
2013-06-30
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis
NCT01967199
Prevail Drug Balloon Study
NCT05562089
Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis
NCT04213378
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
The Clinical Efficacy and Safety of Drug-coated Balloon
NCT05133921
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Drug-eluting balloon
Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter \> 2.25 mm and ≤ 2.75 mm)
SeQuent® Please Drug-eluting balloon
Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length \< 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SeQuent® Please Drug-eluting balloon
Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length \< 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \< 25 mm)
* Informed consent
Exclusion Criteria
* Severe calcified lesion
* Left main coronary lesion
* Lesion having intravascular thrombus
* Shock status from any cause including cardiogenic shock
* Left ventricular ejection fraction \< 30%
* Need for coronary artery bypass surgery
* Allergic reaction for paclitaxel
* Severe allergic for contrast agent (Visipaque) or statin
* Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
OTHER
Inje University
OTHER
Chonnam National University Hospital
OTHER
Ulsan University Hospital
OTHER
Jeju National University Hospital
OTHER
Daegu Catholic University Medical Center
OTHER
Chungbuk National University
OTHER
Dankook University
OTHER
The Catholic University of Korea
OTHER
Kwandong University Myongji Hospital
UNKNOWN
Kosin University Gospel Hospital
OTHER
Keimyung University Dongsan Medical Center
OTHER
Soonchunhyang University Hospital
OTHER
National Health Insurance Service Ilsan Hospital
OTHER
Saint Carollo General Hospital
UNKNOWN
Chuncheon Sacred Heart Hospital
OTHER
Sejong General Hospital
OTHER
Cheju Halla General Hospital
OTHER
Wonkwang University
OTHER
Konyang University Hospital
OTHER
Gangnam Severance Hospital
OTHER
Hallym University Medical Center
OTHER
Chonbuk National University Hospital
OTHER
Korea University Guro Hospital
OTHER
Gachon University Gil Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Woong Chol Kang
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Woong Chul Kang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gachon University Gil Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gachon University Gil Medical Center
Incheon, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DEB-ONLY
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.