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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04744571
• Other study ID #: DCB at CTO
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 2021
• Est. completion date: January 2023

Study information

• Verified date: February 2021
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Device:
• coronary wires. or coronary balloons
all species of coronary wires, or plain balloons

Other:
• drug-coated balloon
Drug-coated balloon including all sizes and all brands

Device:
• drug-eluting stent
Drug-eluting stent including all sizes and all brands

Locations

Country	Name	City	State
China	Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of the incidence of adverse cardiac events between two groups in the perioperative period	Outcome measures including acute coronary artery occlusion, acute vascular perforation, acute stent thrombosis, acute myocardial infarction, and cardiac death	7 days before and after procedure
Primary	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	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
Secondary	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