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Coronary Artery DiseaseFWHZ-DCBNCT06620458

Influencing Factors and Outcomes of DCB Angioplasty

An observational study of Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This ambiprospective observational study evaluates the long-term safety and efficacy of Paclitaxel Drug-Coated Balloon (DCB) angioplasty in approximately 20,000 patients withcoronary artery lesions in large vessels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
5,000 participants
Where
1 siteChina
Study dates
1 Oct 2024to 1 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, China, 450003

Other trials in China

About this study

Official title: 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 20,000 patients withcoronary 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).

Read the 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 withcoronary artery lesions in large vessels. The study aims to enroll approximately 20,000 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.

Keywords
DCB CHD IVUS OCT
Medical subject headings
Coronary Artery Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Vessel Failure (TVF)

    Composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target vessel revascularization, defined according to the Academic Research Consortium (ARC) criteria.

    Measured: From the index procedure through up to 10 years of follow-up

Secondary outcomes (11)

  1. Target Lesion Revascularization (TLR)

    Repeat percutaneous intervention or surgical bypass of the target lesion due to restenosis or other complications.

    Measured: From the index procedure through up to 10 years of follow-up

  2. Target Vessel Revascularization (TVR)

    Any repeat revascularization of the target vessel

    Measured: From the index procedure through up to 10 years of follow-up

  3. Major Adverse Cardiovascular Events (MACE)

    Composite of all-cause death, myocardial infarction, stroke, or any revascularization.

    Measured: From the index procedure through up to 10 years of follow-up

  4. All-cause mortality

    Death from any cause.

    Measured: From the index procedure through up to 10 years of follow-up

  5. Late lumen loss (LLL)

    Difference between post-procedural and follow-up minimal lumen diameter assessed by quantitative coronary angiography.

    Measured: At the first available follow-up coronary angiography, up to 10 years

  6. Binary restenosis

    Diameter stenosis ≥50% at follow-up angiography.

    Measured: At the first available follow-up coronary angiography, up to 10 years

  7. Quantitative Flow Ratio (QFR)

    Functional assessment of coronary physiology derived from angiography.

    Measured: Immediately after the index DCB procedure and at the first available follow-up coronary angiography, up to 10 years

  8. Bleeding Events

    Classified by BARC (Type 1-5) at 12 months.

    Measured: 12 months after the index procedure

  9. cardiovascular death

    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.

    Measured: Up to 5 years after the index DCB procedure

  10. Myocardial Infarction (MI)

    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.

    Measured: From the index procedure through up to 10 years of follow-up.

  11. Target Vessel Myocardial Infarction (TV-MI)

    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.

    Measured: From the index procedure through up to 10 years of follow-up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start1 Oct 2024
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06620458
Sponsor's protocol ID
HenanICE202403
Acronym
FWHZ-DCB
Status last verified
Oct 2026
First submitted
28 Apr 2024
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Vessel Failure (TVF) (time frame: From the index procedure through up to 10 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06620458.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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