Coronary Artery Disease
Conditions
Keywords
DCB CHD IVUS OCT
Brief summary
This ambiprospective observational study evaluates the long-term safety and efficacy of Paclitaxel Drug-Coated Balloon (DCB) angioplasty in approximately 5,000 patients with de novo coronary 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).
Detailed description
This is a large-scale, ambiprospective (bi-directional), observational cohort study designed to evaluate the efficacy and prognostic factors of Drug-Coated Balloon (DCB) angioplasty in patients with de novo coronary artery lesions in large vessels. The study aims to enroll approximately 5,000 patients, comprising both a retrospective cohort (historical data) and a prospective cohort (ongoing recruitment). The primary objective is to investigate the impact of various determinants on clinical and angiographic outcomes. Specifically, the study will analyze differences in: Baseline Characteristics: Demographics, comorbidities, and medication history. Lesion Features: Angiographic morphology, calcification, and lesion length. Intravascular Imaging: Quantitative and qualitative analysis using Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS). Hemodynamic Parameters: Functional assessment indices such as Quantitative Flow Ratio (QFR) or Fractional Flow Reserve (FFR). Procedural Approaches: Pre-dilation techniques, balloon sizing ratios, and inflation duration. Biological Specimen Collection: For the prospective cohort, biological samples (including peripheral venous blood) will be collected at baseline. These samples will be processed to isolate serum, plasma, and DNA/RNA for biobanking. The aim is to identify potential biomarkers (e.g., inflammatory markers, genetic polymorphisms, or metabolic profiles) associated with vascular remodeling, neointimal hyperplasia, and late lumen loss following DCB treatment. Endpoints and Follow-up: The study is designed to assess clinical and angiographic outcomes longitudinally. Follow-up assessments will be conducted at scheduled intervals (e.g., 1 year) and will extend to very long-term follow-up (up to 10 years). This extended observation period aims to evaluate the durability of the procedure and the long-term safety profile. Clinical Endpoints: Major Adverse Cardiovascular Events (MACE), defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. Angiographic Endpoints: Late Lumen Loss (LLL) and Binary Restenosis Rate assessed by Quantitative Coronary Angiography (QCA) at designated angiographic follow-up windows.
Interventions
None listed
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Revascularization (TLR) | From the index procedure through up to 10 years of follow-up | Repeat percutaneous intervention or surgical bypass of the target lesion due to restenosis or other complications. |
| Target Vessel Revascularization (TVR) | From the index procedure through up to 10 years of follow-up | Any repeat revascularization of the target vessel |
| Major Adverse Cardiovascular Events (MACE) | From the index procedure through up to 10 years of follow-up | Composite of all-cause death, myocardial infarction, stroke, or any revascularization. |
| All-cause mortality | From the index procedure through up to 10 years of follow-up | Death from any cause. |
| Late lumen loss (LLL) | At the first available follow-up coronary angiography, up to 10 years | Difference between post-procedural and follow-up minimal lumen diameter assessed by quantitative coronary angiography. |
| Binary restenosis | At the first available follow-up coronary angiography, up to 10 years | Diameter stenosis ≥50% at follow-up angiography. |
| Quantitative Flow Ratio (QFR) | Immediately after the index DCB procedure and at the first available follow-up coronary angiography, up to 10 years | Functional assessment of coronary physiology derived from angiography. |
| Bleeding Events | 12 months after the index procedure | Classified by BARC (Type 1-5) at 12 months. |
| cardiovascular death | Up to 5 years after the index DCB procedure | Death due to cardiovascular causes, including death caused by acute myocardial infarction, sudden cardiac death (including unwitnessed death), heart failure, stroke, cardiovascular procedures, or cardiovascular hemorrhage, according to the Drug-Coated Balloon Academic Research Consortium (DCB-ARC) criteria. |
| Myocardial Infarction (MI) | From the index procedure through up to 10 years of follow-up. | Occurrence of myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction. Both target-vessel and non-target-vessel myocardial infarctions will be recorded. |
| Target Vessel Myocardial Infarction (TV-MI) | From the index procedure through up to 10 years of follow-up. | Myocardial infarction attributable to the target vessel. This includes myocardial infarction related to the DCB-treated target lesion and myocardial infarction arising from a non-target lesion within the same target vessel. |
Countries
China
Contacts
STUDY_CHAIRMuwei Li, Ph.D
Fuwai central China cardiovascular hospotial
Outcome results
None listed