The Clinical Efficacy and Safety of Drug-coated Balloon
NCT ID: NCT05133921
Last Updated: 2026-02-12
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.
COMPLETED
2487 participants
OBSERVATIONAL
2015-12-01
2020-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES.
Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion.
Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\<30% post-DCB, maintaining TIMI flow=3, DCB dilation time\<60s, and appropriate balloon to vessel ratio\> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice.
This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients
NCT05937230
Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions
NCT04022200
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
NCT04937803
Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions
NCT05552911
Safety and Efficacy of DCB Therapy for ISR Under the Guidance of QFR (UNIQUE-DCB-II Study )
NCT04119986
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.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patients who did not received drug-eluting stent implantation
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xijing Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ling Tao, MD, PhD
Professor in Cardiology, Director of the department of Cardiology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ling Tao, MD, Ph.D.
Role: STUDY_CHAIR
Xijing Hospital
Chao Gao, MD, Ph.D.
Role: STUDY_CHAIR
Xijing Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ling Tao
Xi'an, Shannxi, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAGE-FREE registry
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.