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

NCT ID: NCT04744571

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-28
• Study Completion Date: 2023-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DCB group

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

Group Type: EXPERIMENTAL

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

Intervention Type: DRUG

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.

coronary wires. or coronary balloons

Intervention Type: DEVICE

all species of coronary wires, or plain balloons

drug-coated balloon

Intervention Type: OTHER

Drug-coated balloon including all sizes and all brands

DES group

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

Group Type: ACTIVE_COMPARATOR

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

Intervention Type: DRUG

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.

coronary wires. or coronary balloons

Intervention Type: DEVICE

all species of coronary wires, or plain balloons

drug-eluting stent

Intervention Type: DEVICE

Drug-eluting stent including all sizes and all brands

Interventions

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

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.

Intervention Type: DRUG

coronary wires. or coronary balloons

all species of coronary wires, or plain balloons

Intervention Type: DEVICE

drug-coated balloon

Drug-coated balloon including all sizes and all brands

Intervention Type: OTHER

drug-eluting stent

Drug-eluting stent including all sizes and all brands

Intervention Type: DEVICE

Other Intervention Names

Optimal medical therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiantao Song, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

xiantao song, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

DCB at CTO

Identifier Type: -

Identifier Source: org_study_id