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Dissolvable heart scaffolds take on drug balloons in major artery showdown

NCT ID NCT07162792

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study will compare two modern treatments for blocked coronary arteries: a new-generation bioabsorbable scaffold (a temporary mesh that dissolves over time) and a drug-coated balloon (a balloon that releases medication to prevent re-blockage). 150 patients with blockages in large heart arteries will be randomly assigned to one of the two treatments. The main goal is to see which approach keeps the artery more open one year later, with follow-up continuing for five years.

What this could mean

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

Active substance
bioresorbable scaffold (Firesorb) and drug-coated balloon
What this could lead to
If successful, this could show that a dissolvable scaffold is a safe and effective alternative to drug-coated balloons for treating large heart arteries, potentially reducing the need for permanent implants.
What could go wrong
This is a relatively small, early-stage study (150 patients) that has not yet started recruiting. The results may not apply to all patients, and there is a risk that the scaffold could cause late complications like clotting or re-narrowing.

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

About 150 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

Dec 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.

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: * \- Radiography inclusion criteria 1. angiographically confirmed de novo coronary artery lesion; 2. target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment); 3. target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤25mm (visual assessment); 4. either one or two target lesions to be treated; if two target lesions, they must be located in different target vessels; 5. successful target lesion preparation: residual stenosis ≤30%, no flow-restricting entrapment, and TIMI grade 3 flow; General inclusion criteria <!-- --> 1. subjects at the age between ≥18 and ≤80 years old; 2. patients with symptoms or evidence of myocardial ischaemia; 3. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up after operation. Exclusion Criteria: * 1\. in-stent lesions; 2. For the left main disease, chronic total occlusive lesions; 3. bifurcation lesion (reference vessel diameter of side branch vessels \> 2.0 mm); 4. Severely calcified lesions and tortuous lesions; lesions that have failed pretreatment; lesions unsuitable for balloon delivery and dilatation; 5. Previous use of any brand of drug-coated balloon in the target vessel. General inclusion criteria 1. Any patient with myocardial infarction within one month; 2. Patients with severe congestive heart failure (NYHA Level III severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 40%; 3. Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders; 4. Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators; 5. Patients with severe renal failure(eGFR\<30ml/minute) or such medical history, failure to comply with angiography conditions; 6. Subjects who are intolerance or allergic to heparin, contrast agent, polyethylene oxide and polylactic acid - glycolic acid polymer; 7. Patients who plans to accept selective operation within 1 year; 8. Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint; 9. Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.

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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.

How to take part

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  1. 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 ↗

  2. A doctor treating you

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