NCT06620458Enrolling by invitation
Influencing Factors and Outcomes of DCB Angioplasty
Analysis of Prognostic Factors for Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease: An Ambiprospective Cohort Study
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 5000 (estimated)
- First submitted
- 28 Apr 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Diseases
- Coronary artery disease
- NCT number
- NCT06620458
What you commit to
- Study type: Observational
- Planned participants: 5000
- From 1 Oct 2024 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Central China Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.