Influencing Factors and Outcomes of DCB Angioplasty (FWHZ-DCB)

August 17, 2026 updated by: Henan Institute of Cardiovascular Epidemiology

Analysis of Prognostic Factors for Drug-Coated Balloon Angioplasty in Patients With Coronary Artery Disease: An Ambiprospective Cohort Study

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).

Study Overview

Status

Enrolling by invitation

Conditions

Coronary Artery Disease

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- China
  - Zhengzhou, China, China, 450003
    - Fuwai Central China Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

This study targets adults aged 18 and over who have been diagnosed with coronary artery disease featuring native large vessel lesions and are scheduled to undergo paclitaxel drug-coated balloon angioplasty.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Vessel Failure (TVF) Time Frame: 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.	From the index procedure through up to 10 years of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Revascularization (TLR) Time Frame: 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.	From the index procedure through up to 10 years of follow-up
Target Vessel Revascularization (TVR) Time Frame: From the index procedure through up to 10 years of follow-up	Any repeat revascularization of the target vessel	From the index procedure through up to 10 years of follow-up
Major Adverse Cardiovascular Events (MACE) Time Frame: From the index procedure through up to 10 years of follow-up	Composite of all-cause death, myocardial infarction, stroke, or any revascularization.	From the index procedure through up to 10 years of follow-up
All-cause mortality Time Frame: From the index procedure through up to 10 years of follow-up	Death from any cause.	From the index procedure through up to 10 years of follow-up
Late lumen loss (LLL) Time Frame: 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.	At the first available follow-up coronary angiography, up to 10 years
Binary restenosis Time Frame: At the first available follow-up coronary angiography, up to 10 years	Diameter stenosis ≥50% at follow-up angiography.	At the first available follow-up coronary angiography, up to 10 years
Quantitative Flow Ratio (QFR) Time Frame: 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.	Immediately after the index DCB procedure and at the first available follow-up coronary angiography, up to 10 years
Bleeding Events Time Frame: 12 months after the index procedure	Classified by BARC (Type 1-5) at 12 months.	12 months after the index procedure
cardiovascular death Time Frame: 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.	Up to 5 years after the index DCB procedure
Myocardial Infarction (MI) Time Frame: 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.	From the index procedure through up to 10 years of follow-up.
Target Vessel Myocardial Infarction (TV-MI) Time Frame: 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.	From the index procedure through up to 10 years of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Institute of Cardiovascular Epidemiology

Investigators

Study Chair: Muwei Li, Ph.D, Fuwai central China cardiovascular hospotial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)