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

Capital Medical University

Status: Unknown

Conditions: Drug-Eluting Stents; Coronary Artery Disease; Percutaneous Coronary Intervention; Chronic Total Occlusion of Coronary Artery; Coronary Occlusion

Treatments: Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. or coronary balloons; Device: drug-eluting stent; Other: drug-coated balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT04744571

DCB at CTO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patients between 18 and 80 years of age
• Must comply all the evaluations and follow-up protocols
• Clinical diagnosis of CTO detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis)
• Patients should present with left ventricular ejection fraction (LVEF) above 35% determined using transthoracic echocardiography
• CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm

Exclusion Criteria

• Patients have suffered from acute myocardial infarction within the previous 3 months
• Lesion located in the left main artery (stenosis ≥50%)
• Clinical diagnosis of rheumatic valvular disease
• Clinical diagnosis of severe arrhythmia
• With history of revascularization within the CTO artery
• Lesions unsuitable for PCI
• Severely abnormal hematopoietic systems, such as platelet counts <100 x 109/L or > 700 x 109/ L and white blood cell counts < 3 x 109/L
• Patients with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency)
• Patients with severe coexisting condition including: severe renal function dysfunction [Glomerular filtration rate (GFR) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders, tumors, surgery within 3 months, a life expectancy less than 12 months, pregnancy or planning to become pregnant, history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents
• Patients cannot tolerate dual antiplatelet treatment (DAPT)
• Patients are unable to communicate due to cognitive impairment, auditory or visual impairment
• Patients are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

DCB group

Experimental group

Description:

Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions

Treatment:

Device: coronary wires. or coronary balloons

Other: drug-coated balloon

Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

DES group

Active Comparator group

Description:

Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions

Treatment:

Device: drug-eluting stent

Device: coronary wires. or coronary balloons

Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor