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Clinical Trials in China / NCT06620458
Enrolling by invitation Observational

Influencing Factors and Outcomes of DCB Angioplasty

NCT06620458 · tracked via the Priya Life Science China tracker
Sponsor
Henan Institute of Cardiovascular Epidemiology
Phase
Observational
Started
2024-10-01
Last updated
2026-10-09

Condition(s) studied

Coronary Artery Disease

Study summary

This ambiprospective observational study evaluates the long-term safety and efficacy of Paclitaxel Drug-Coated Balloon (DCB) angioplasty in approximately 20,000 patients withcoronary artery lesions in large vessels. By combining retrospective historical data with a prospective registry involving biological specimen collection, the study aims to identify key predictors of outcomes, including intravascular imaging findings, hemodynamic parameters, and biological markers. Patients will be followed longitudinally for up to 10 years to assess the durability of the treatment and the incidence of major adverse cardiovascular events (MACE).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age: 18 years and older. * Diagnosis: Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography. * Treatment Plan: Scheduled to receive paclitaxel drug-coated balloon angioplasty. * Informed Consent: Patients have been fully informed about the nature and purpose of the study, and have voluntarily agreed to participate, with signed informed consent. * Physiological Status: Cardiac function classified as NYHA I-III. Exclusion Criteria: * Allergy History: Known allergies to paclitaxel or any materials used in angioplasty (e.g., contrast agents). * Severe Complications: Uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg). * Other Medical Conditions: Active bleeding or clotting disorders. * Other serious diseases with a life expectancy of less than 1 year (e.g., advanced cancer). * Pregnancy or Nursing: Women who are currently pregnant or breastfeeding. * Participation in Other Studies: Currently participating in other clinical trials that might affect the results of this study. * Psychological or Behavioral Factors: History of psychiatric or behavioral disorders that could interfere with adherence to study protocols, or communication barriers that prevent understanding of study requirements.

Primary outcome measure(s)

  • Target Vessel Failure (TVF) — From the index procedure through up to 10 years of follow-up
    Composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target vessel revascularization, defined according to the Academic Research Consortium (ARC) criteria.

Trial sites (1)

FacilityCityRegionStatus
Fuwai Central China Cardiovascular Hospital Zhengzhou China

More Henan Institute of Cardiovascular Epidemiology trials in China

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Other trials for the same condition

IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions Active, not recruiting
SGLT2 Inhibitors on Coronary Atherosclerosis Progression Via Perivascular Adipose Tissue in Diabetes Recruiting
Prospective Study Protocol for Multiparametric PCCT Assessment of Early Ventricular Outcomes After CABG Recruiting
Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol Recruiting
Sedentary Behavior Intervention for Older Adults With Coronary Heart Disease and Frailty Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06620458 on ClinicalTrials.gov ↗ ← All trials in China