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New balloon technique may lower heart risks after stenting

NCT ID NCT04242134

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a drug-coated balloon (DCB) instead of a standard balloon for the side branch of a heart artery after stenting can reduce the chance of major heart problems like heart attack or death within one year. About 784 adults with coronary artery disease and true bifurcation lesions (where the main artery splits) are taking part. The goal is to see if the DCB approach leads to fewer heart-related events.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

784 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jun 2026

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.

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: 1. Subject must be age ≥18 years. 2. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. 3. Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed. 4. Subject is willing to comply with all protocol-required follow-up evaluations. 5. Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). 6. Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation. 7. Target lesion must have visually estimated stenosis ≥50%. 8. Target lesion length of side branch must be \<10 mm by visual estimation. 9. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel. Exclusion Criteria: 1. Patient with STEMI (within 1-week from the onset of chest pain to admission). 2. Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications. 3. Patient is intolerable to dual anti-platelet therapy. 4. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. 5. Patient is pregnant or nursing. 6. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. 7. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. 8. Restenotic lesion. 9. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized. 10. Severe calcification needing rotational atherectomy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006, China

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