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

Not Applicable

• Conditions: Coronary Artery Disease; Coronary Occlusion; Chronic Total Occlusion of Coronary Artery; Percutaneous Coronary Intervention; Drug-Eluting Stents
• Interventions: Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. or coronary balloons; Other: drug-coated balloon; Device: drug-eluting stent

• Registration Number: NCT04744571
• Lead Sponsor: Beijing Anzhen Hospital

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.

Study Timeline

• Status Verified: 2021-02
• Study Start: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-06
• Last Update Submitted: 2021-02-06
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09
• Primary Completion: 2022-12
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES group	aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor	Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
DCB group	aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor	Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
DCB group	coronary wires. or coronary balloons	Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
DCB group	drug-coated balloon	Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
DES group	coronary wires. or coronary balloons	Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
DES group	drug-eluting stent	Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions

Primary Outcome Measures

Name	Time	Method
Comparison of the difference in minimal lumen diameter (MLD) between two groups	12 months	Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
Comparison of the incidence of major adverse cardiac events（MACEs） between two groups	12 months	all-cause mortality, cardiac death, a first or recurrent, non-fatal, acute myocardial infarction, target lesion revascularization (PCI or CABG), stroke, heart failure and cardiac rehospitalization
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	Myocardial viability in the territory supplied by the CTO artery by comparison of late gadolinium enhancement between two groups.

Trial Locations

Locations (1)

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China