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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
* Device: coronary wires. or coronary balloons
* Other: drug-coated balloon
* Device: drug-eluting stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB group<br>Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions | Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor<br>* 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.<br>* Other names: Optimal medical therapy;Device: coronary wires. or coronary balloons<br>* all species of coronary wires, or plain balloons<br>Other: drug-coated balloon<br>* Drug-coated balloon including all sizes and all brands<br>|
| Active Comparator: DES group<br>Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions | Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor<br>* 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.<br>* Other names: Optimal medical therapy;Device: coronary wires. or coronary balloons<br>* all species of coronary wires, or plain balloons<br>Device: drug-eluting stent<br>* Drug-eluting stent including all sizes and all brands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the difference in minimal lumen diameter (MLD) between two groups | Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the incidence of major adverse cardiac events（MACEs） between two groups | 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 | 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) | Myocardial viability in the territory supplied by the CTO artery by comparison of late gadolinium enhancement between two groups. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Total Occlusion, drug-coated balloon, balloon angioplasty, drug-eluting stent