A Retrospective Study on the Factors of Drug-coated Balloon Restenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This study is a retrospective analysis that retrospectively reviewed over approximately 5000 patients with de novo-large-vessel disease who underwent paclitaxel drug-coated balloon angioplasty. The study endpoints include cardiovascular adverse events at 1 year (cardiovascular death, cardiovascular events) and coronary angiographic outcomes (primarily late lumen loss, restenosis rate). It primarily focuses on differences in baseline characteristics, lesion features, intracavitary imaging characteristics(Including OCT, IVUS), hemodynamic parameter，and procedural approaches among patients. Over 5000 patients are expected to be enrolled.
Primary outcome measures
- MACE [Time frame: 12 months]
Secondary outcome measures (1)
- LLL(late lumen loss) [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fuwai Central China Cardiovascular Hospital — Zhengzhou
Identifiers
NCT: NCT06620458 · HenanICE202403