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Can balloon timing make or break heart artery success?

NCT ID NCT07764094

Knowledge-focused Sponsor: Nanjing First Hospital, Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 13, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tracks 500 adults with stable coronary artery disease or unstable angina who are undergoing a heart procedure called percutaneous coronary intervention (PCI) using a drug-coated balloon. Researchers are looking at how procedural details—specifically how long the balloon takes to reach the blockage and how long it stays inflated—affect the artery's healing and future heart health. The goal is to see whether these factors influence the chance of the artery narrowing again or causing heart-related complications later on.

What this could mean

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

Active substance
Drug-coated balloon
What this could lead to
If successful, this could help doctors refine how they use drug-coated balloons during heart procedures, potentially improving long-term outcomes for patients with coronary artery disease.
What could go wrong
This is an observational registry, not a controlled trial, so it can only show associations, not cause and effect. Results may be influenced by unmeasured factors and may not apply to all patients.

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 500 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

Patients with de novo coronary lesions who are scheduled for planned drug-coated balloon PCI

Ages

18 to 80 years

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: 1. Age ≥18 years 2. Stable coronary artery disease or unstable angina 3. De novo coronary lesion (reference vessel diameter 2.25-4.0 mm; lesion length ≤40 mm) 4. Planned DCB strategy for PCI 5. Written informed consent Exclusion Criteria: 1. Acute myocardial infarction within 72 hours 2. Severe heart failure (NYHA class IV) 3. Severe hepatic or renal insufficiency 4. Allergy to drug-coated balloon components or antiplatelet agents, or intolerance to dual antiplatelet therapy 5. Life expectancy \<12 months 6. Pregnancy or breastfeeding 7. Concurrent participation in another clinical trial 8. In-stent restenosis 9. Unsuccessful recanalization of main vessel or side branch chronic total occlusion 10. Hemodynamic instability

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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 Drug coated balloon PCI

How to take part

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

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Chuzhou First People's Hospital

    RECRUITING

    Chuzhou, Anhui, 239000, China

  • Huai'an Second People's Hospital

    RECRUITING

    Huai'an, Jiangsu, 223000, China

  • Lianyungang First People's Hospital

    RECRUITING

    Lianyungang, Jiangsu, 222000, China

  • Nanjing First Hospital

    RECRUITING

    Nanjing, Jiangsu, 210006, China

  • Tongling People's Hospital

    RECRUITING

    Tongling, Anhui, 244000, China

  • Xuzhou Second People's Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

  • Yixing People's Hospital

    RECRUITING

    Yixing, Jiangsu, 214200, China

More trials for these conditions

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