Dissolvable heart stent could replace metal ones in major trial

NCT ID NCT07022587

Disease control Sponsor: Xijing Hospital Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new dissolvable heart stent (Firesorb BRS) to a standard metal stent in 2000 people with coronary artery disease. The dissolvable stent is designed to support the artery temporarily and then disappear, potentially avoiding long-term risks of permanent stents. The main goal is to see if it works just as well at preventing heart-related events like heart attacks or repeat procedures.

What this could mean

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

Active substance: sirolimus
What this could lead to: If successful, this could offer a safer alternative to permanent metal stents, reducing long-term complications like late blood clots.
What could go wrong: This is a non-inferiority trial, meaning it aims to show the new scaffold is not worse than the current standard. Earlier dissolvable stents had higher clot risks, so caution is warranted.

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 2,000 people

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

Started

Dec 2025

Expected to finish

Dec 2073

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 75 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: Clinical inclusion criteria 1. Patients with an indication for PCI due to acute or chronic coronary syndrome 2. Patients who understand the study's objectives, voluntarily participate, sign the informed consent form, and are willing to undergo regular follow-up Angiographic inclusion criteria 1. De novo lesion(s) 2. Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation) 3. Target lesion is NOT 1. Severely calcified 2. In-stent restenosis 3. Diffused lesion requiring stent overlapping or more than one stent 4. Located in the left main, aorto-ostial, proximal LAD/LCX/RCA involving vessel ostia (stent coverage required within 3 mm of vessel ostia), surgical graft, myocardial bridge, or chronic total occlusion 5. Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter 6. Located in the target vessel with severe tortuosity Exclusion Criteria: 1. Age \< 18 years, or \> 75 years 2. Patient is a woman who is pregnant or nursing 3. Patients who have received any stent implantation in the target vessel within one year 4. Patients required long-term oral anticoagulation 5. Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk 6. Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast 7. Currently participating in another trial and not yet at its primary endpoint 8. Patients whose life expectancy is less than 3 years 9. Cardiogenic shock

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary stenosis

As listed by the trial registrant

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

Coronary artery disease De novo stenosis

How to take part

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

The places running it

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

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

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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.

Dissolvable heart stent could replace metal ones in major trial

What the study statuses mean