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Can a shorter course of blood thinners work after Metal-Free heart balloons?

NCT ID NCT07815106

Disease control Sponsor: Shanghai Zhongshan Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Drug-coated balloons open narrowed heart arteries without leaving a metal stent behind. Because the drug acts only briefly, researchers want to know if patients can safely take dual antiplatelet therapy for just 1 month instead of the usual 6 months. The trial enrolls people with chronic coronary syndrome who have been treated with a drug-coated balloon and compares the two treatment lengths, tracking vessel failure and bleeding over 1 year.

What this could mean

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

Active substance
dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor)
What this could lead to
If shorter treatment proves just as safe, people treated with drug-coated balloons could spend less time on blood thinners and face fewer bleeding risks.
What could go wrong
The trial may show that 1 month of antiplatelet therapy is not enough to prevent vessel failure, and stopping blood thinners early can raise the risk of clots. Results may not apply to people with more complex heart lesions.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,122 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Diagnosed with chronic coronary syndrome (CCS); 2. Underwent DCB treatment, with no ischemic or bleeding events within 1 month after the procedure; 3. Received dual antiplatelet therapy consisting of aspirin plus a P2Y₁₂ receptor inhibitor; 4. Agreed to participate in the study. Exclusion Criteria: 1. Left-main lesion; or lesion location/characteristics (e.g., heavy tortuosity, severe focal calcification, complex bifurcation lesions, slow-flow phenomenon) precluding a DCB-only strategy; 2. Severe calcified lesions with residual calcium-plate support \>50% after lesion pre-treatment; 3. Stroke occurring within the recent 3 months, or patients requiring routine anticoagulation therapy; 4. Severe hepatic or renal insufficiency (eGFR \< 30 mL/min), bleeding diathesis, or recent major bleeding; 5. Infertile or pregnant female patients; any factors that may interfere with follow-up or participation in other studies; 6. Patients unable to comply with study requirements, with estimated survival \< 1 year, or those with psychological or other factors hindering complete follow-up; 7. Patients deemed ineligible for participation in this study by the investigators.

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As listed by the trial registrant

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

Chronic coronary syndrome

How to take part

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  1. The official record

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