Clinical Trials Logo

Clinical Trial Summary

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.


Clinical Trial Description

Although several reports suggested that DCB application was safe for larger coronary artery lesions and showed good long-term outcomes, there is limited randomised controlled trial (RCT) data on the safety and efficacy of DCB in large coronary artery disease. Therefore, the study aims to demonstrate the non-inferiority of the drug-coated balloon (DCB) treatment against current-generation drug-eluting stenting (DES) in patients with de novo lesions in large coronary artery disease (reference vessel diameter ≥3.0 mm by visual estimation). The hypothesis of the study is the clinical outcomes of patients treated with DCB are non-inferior to those treated with current-generation DES. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05846893
Study type Interventional
Source B. Braun Medical Industries Sdn. Bhd.
Contact Hooi Sian Eng, Ph.D
Phone +60-12-428-2880
Email hooi.eng@bbraun.com
Status Recruiting
Phase N/A
Start date September 7, 2023
Completion date September 2028

See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A
Recruiting NCT04310046 - Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial N/A