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Can a Drug-Coated balloon keep heart arteries open for a decade?

NCT ID NCT06620458

Knowledge-focused Sponsor: Henan Institute of Cardiovascular Epidemiology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study follows about 5,000 people with coronary artery disease who are treated with a paclitaxel drug-coated balloon angioplasty, a procedure that opens narrowed heart arteries and releases medication to help keep them open. Researchers are combining past medical records with new data, including blood samples and imaging, to identify factors that predict long-term success. Participants will be tracked for up to 10 years to see how often major heart events occur and how durable the treatment is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paclitaxel drug-coated balloon angioplasty
What this could lead to
If successful, this could help doctors predict which patients with coronary artery disease will benefit most from drug-coated balloon angioplasty, improving long-term outcomes.
What could go wrong
This is an observational study, not a randomized trial, so it cannot prove cause and effect. Results may be influenced by patient differences, and long-term follow-up may be incomplete.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, China, 450003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.