Clinical trial NCT04744571: Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Official title: Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Coronary Occlusion
Percutaneous Coronary Intervention
Chronic Total Occlusion of Coronary Artery
Drug-Eluting Stents
Keywords: Chronic Total Occlusion
drug-coated balloon
balloon angioplasty
drug-eluting stent
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Comparison of the difference in minimal lumen diameter (MLD) between two groups
timeFrame: 12 months
Secondary outcomes:
measure: Comparison of the incidence of major adverse cardiac events（MACEs） between two groups
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Other outcomes:
measure: Comparison of the incidence of adverse cardiac events between two groups in the perioperative period
timeFrame: 7 days before and after procedure
Locations:
city: Beijing
country: China
facility: Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: xiantao song, MD
role: PRINCIPAL_INVESTIGATOR
References: