Status:
UNKNOWN
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Coronary Artery Disease
Coronary Occlusion
Eligibility:
All Genders
18-80 years
Phase:
NA
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 ou...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04744571
Start Date
February 1 2021
End Date
January 1 2023
Last Update
February 9 2021
Active Locations (1)
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1
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029