A Retrospective Study on the Factors of Drug-coated Balloon Restenosis
Recruiting now
Conditions studied: Coronary Artery Disease
In brief
The purpose of this study is to analyze potential factors post paclitaxel drug-coated balloon angioplasty in patients with Denovo large vessels disease. It includes imaging endpoints and clinical event endpoints. Over 5000 patients are expected to be enrolled.
Key facts
- Study ID
- NCT06620458
- Run by
- Henan Institute of Cardiovascular Epidemiology
- People needed
- 5000
- Starts
- 2024-10-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fuwai Central China Cardiovascular Hospital — Zhengzhou, China (enrolling)
Full record on ClinicalTrials.gov
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