Clinical Trials Logo
  1. Home
  2. Coronary Artery Disease
  3. NCT06002932

Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. — PROVISIONDEB  

Coronary Artery Disease Clinical Trial

Official title:
Comparison of PROVISIONal 1-stent Strategy With Drug-Eluting Balloon Versus Planned 2-stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions.

Clinical Trial Summary

[The Purpose of the Clinical Study] The purpose of this randomized comparison study is to compare the 1-stent strategy with a drug-eluting balloon and the 2-stent strategy in patients with non-LM coronary true-bifurcation lesions. [Hypothesis] In this study, the researchers intend to verify the hypothesis that the 1-stent strategy with a drug-eluting balloon is non-inferior to the 2-stent strategy in terms of target lesion failures (cardiac death, target vessel MI, or target vessel revascularization).

Clinical Trial Description

1. Provisional 1-stent plus DEB strategy As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branch vessel. The order of the treatments done to the main vessel and the branch vessel shall be at the discretion of the treatment provider. Also, at the discretion of the treatment provider, a bail-out stenting can still be performed, depending on the condition of the branch vessel following a drug-eluting balloon treatment. However, bail-out stenting is recommended if there is a TIMI flow disorder, severe coronary artery exfoliation (National Heart, Lung, and Blood Institute type D, E, or F), or significant residual stenosis. 2. Planned 2-stent strategy As per the conventional treatment process, this strategy treats both the main vessel and the branch vessel with stents. The decision among Crush (Mini-crush), DK-Crush, Cullotte, TAP, and T-stenting is left to the discretion of the treatment provider. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06002932
Study type Interventional
Source Saint Vincent's Hospital, Korea
Contact Sung-Ho Her, MD. PhD.
Phone +82312598397
Email hhhsungho@naver.com
Status Recruiting
Phase N/A
Start date September 8, 2023
Completion date December 31, 2028
View Details
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
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease 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
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
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 Korean Patients With 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