Actively Recruiting
A Retrospective Study on the Factors of Drug-coated Balloon Restenosis in Coronary Artery Disease
Led by Henan Institute of Cardiovascular Epidemiology · Updated on 2024-11-14
5000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are analyzing factors that affect outcomes after paclitaxel drug-coated balloon angioplasty in patients with de novo large-vessel coronary artery disease. This retrospective study reviews data from over 5000 patients to understand differences in baseline characteristics, lesion features, imaging results, hemodynamic parameters, and procedural approaches. The main focus is on cardiovascular events and angiographic outcomes at one year following treatment. The study involves reviewing records of patients who underwent paclitaxel drug-coated balloon angioplasty. It evaluates clinical events such as cardiovascular death and other cardiovascular complications within 12 months. Imaging outcomes like late lumen loss and restenosis rates are also assessed, including intracavitary imaging techniques such as OCT and IVUS. The study is observational and does not involve new treatments or interventions. Participants will have their medical and imaging data reviewed retrospectively. Researchers will measure major adverse cardiovascular events at 12 months and assess changes in the treated vessels using coronary angiography. The study includes patients aged 18 and older with confirmed large vessel coronary artery disease. Safety and clinical outcomes will be monitored through the review of existing clinical information and imaging records. The study is expected to be completed by the end of 2026.
CONDITIONS
Brief Title
A Retrospective Study on the Factors of Drug-coated Balloon Restenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older
- Diagnosed with coronary artery disease with native large vessel lesions confirmed by coronary angiography
- Scheduled to receive paclitaxel drug-coated balloon angioplasty
- Provided signed informed consent after being fully informed about the study
- Cardiac function classified as NYHA I-III
You will not qualify if you...
- Known allergies to paclitaxel or any materials used in angioplasty such as contrast agents
- Uncontrolled hypertension with systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg
- Active bleeding or clotting disorders
- Other serious diseases with life expectancy less than 1 year, for example advanced cancer
- Women who are pregnant or breastfeeding
- Currently participating in other clinical trials that might affect study results
- History of psychiatric or behavioral disorders that interfere with study adherence or communication barriers preventing understanding of study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo coronary angiography and intracavitary imaging to assess vessel lesions and procedural approaches.
1 visit (in-person)
Duration - 12 months
Participants are observed for cardiovascular events and angiographic outcomes over 12 months after angioplasty.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, China, 450003
Actively Recruiting
Research Team
Q
Quan Guo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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