NCT04744571

Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Coronary Occlusion
• Percutaneous Coronary Intervention
• Chronic Total Occlusion of Coronary Artery
• Drug-Eluting Stents

Interventions

Type	Name	Description
DRUG	aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor	Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate- limiting medication (i.e. Beta- blocker or rate-limiting calcium antagonist) where appropriate. Anti- anginal therapy should be used if the patients have symptom.
DEVICE	coronary wires. or coronary balloons	all species of coronary wires, or plain balloons
OTHER	drug-coated balloon	Drug-coated balloon including all sizes and all brands
DEVICE	drug-eluting stent	Drug-eluting stent including all sizes and all brands

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-12-01
• Completion: 2023-01-01
• First posted: 2021-02-09
• Last updated: 2021-02-09

Locations

1 site across 1 country: China