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Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions | Clinical Trials | Clareo Health

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

NCT04744571•Beijing Anzhen Hospital

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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)
+2 more criteria

Locations (1)

Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 1, 2021

Primary Completion Date

December 1, 2022

Completion Date

January 1, 2023

Last Updated

February 9, 2021

Enrollment

200

ESTIMATED participants

Conditions

Coronary Artery DiseaseCoronary OcclusionPercutaneous Coronary InterventionChronic Total Occlusion of Coronary ArteryDrug-Eluting Stents

Interventions

aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor

DRUG

coronary wires. or coronary balloons

DEVICE

drug-coated balloon

OTHER

drug-eluting stent

DEVICE

ELEVATE High-Risk PCI Pivotal Study

NCT07001332

High-Risk Percutaneous Coronary Intervention (High-risk PCI)

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RECRUITINGPHASE4

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

NCT06909565

Percutaneous Coronary InterventionPeripheral Endovascular Intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ELEVATE High-Risk PCI Pivotal Study

Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention

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