Chronic Total Occlusion of Coronary Artery, Coronary Artery Disease, Coronary Occlusion, Drug-Eluting Stents, Percutaneous Coronary Intervention
Conditions
Keywords
Chronic Total Occlusion, drug-coated balloon, balloon angioplasty, drug-eluting stent
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.
Interventions
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.
DEVICEcoronary wires. or coronary balloons
all species of coronary wires, or plain balloons
OTHERdrug-coated balloon
Drug-coated balloon including all sizes and all brands
DEVICEdrug-eluting stent
Drug-eluting stent including all sizes and all brands
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the incidence of adverse cardiac events between two groups in the perioperative period | 7 days before and after procedure | Outcome measures including acute coronary artery occlusion, acute vascular perforation, acute stent thrombosis, acute myocardial infarction, and cardiac death |
Countries
China
Outcome results
None listed