Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Overview
- Phase
- Not Applicable
- Intervention
- aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
- Conditions
- Coronary Artery Disease
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Comparison of the difference in minimal lumen diameter (MLD) between two groups
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion (CTO) lesion.
Detailed Description
Recruited CTO patients will be divided into two groups: those undergoing PCI of drug-coated balloon (DCB group), and those undergoing PCI of drug eluting stent implantation (DES group). The primary outcome assessed will be the late lumen loss evaluation at a 12-month of follow-up appointment. Secondary outcomes include occurrence of major cardiac events (MACEs), myocardial viability, operate success, quality of life changes which will be compared to a baseline measurement.
Investigators
Xiantao Song, MD
Professor
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
DCB group
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
Intervention: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
DCB group
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
Intervention: coronary wires. or coronary balloons
DCB group
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
Intervention: drug-coated balloon
DES group
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
Intervention: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
DES group
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
Intervention: coronary wires. or coronary balloons
DES group
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
Intervention: drug-eluting stent
Outcomes
Primary Outcomes
Comparison of the difference in minimal lumen diameter (MLD) between two groups
Time Frame: 12 months
Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)
Secondary Outcomes
- Comparison of the incidence of major adverse cardiac events（MACEs） between two groups(12 months)
- Comparison of myocardial viability (late gadolinium enhancement, LGE) in the territory supplied by the CTO artery between two groups evaluated via cardiovascular magnetic resonance (CMR)(12 months)