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

NCT04744571 | Unknown

• 1 other identifier: DCB at CTO
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of the incidence of major adverse cardiac events（MACEs） between two groups

  12 months

• 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

Other Outcomes (1)

• Comparison of the incidence of adverse cardiac events between two groups in the perioperative period

  7 days before and after procedure

Study Arms (2)

DCB group

EXPERIMENTAL

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

Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. or coronary balloons; Other: drug-coated balloon

DES group

ACTIVE COMPARATOR

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

Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. or coronary balloons; Device: drug-eluting stent

Interventions

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor 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.

Also known as: Optimal medical therapy

DCB group; DES group

coronary wires. or coronary balloons DEVICE

all species of coronary wires, or plain balloons

DCB group; DES group

drug-coated balloon OTHER

Drug-coated balloon including all sizes and all brands

DCB group

drug-eluting stent DEVICE

Drug-eluting stent including all sizes and all brands

DES group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Occlusion

Interventions

Aspirin; Metoprolol; Atorvastatin; Rosuvastatin Calcium; Clopidogrel; Ticagrelor; Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines; Ticlopidine; Thienopyridines; Thiophenes; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• xiantao song, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 9, 2021
• Study Start: February 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

CN (1)