NCT07022587Recruiting
Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions
A Bioresorbable Sirolimus-eluting scaffold Versus a Metallic Sirolimus-eluting Stent for the Treatment of de Novo Coronary Artery Lesions: a Randomized, Open-label, Non-inferiority Trial
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
Bioresorbable scaffold (BRS) was designed aiming to avoid the late adverse events associated with permanent metallic stents by providing temporary support to the vessel wall and promoting vessel remodeling, plaque reduction, and restoring vasomotion after its full absorption. As the first FDA-approved BRS, ABSORB BRS was associated with a significantly higher risk of late scaffold thrombosis compared with everolimus-eluting stent (EES). As a result, the ESC-EAPCI task force recommended that the current ABSORB BRS should not be preferred over conventional DES in clinical practice. To solve this dilemma, improved scaffold technology and optimal implantation techniques are necessary. The latest generation Firesorb BRS is a PLLA backbone scaffold system abluminally coated with poly(D, L-lactide) mixed with sirolimus using highly accurate and precise point spraying techniques. Compared to the ABSORB BRS, Firesorb features a thinner stent thickness (100-125 μm) while maintaining sufficient radial support, enabling faster degradation and a shorter duration of presence in the coronary. Additionally, inspired by the design of the Firehawk DES, its unique spot-coating process applies a single-sided coating layer exclusively to the stent's outer surface, enabling targeted drug release. Preclinical trials have demonstrated favorable performance for Firesorb, culminating in its approval by the National Medical Products Administration (NMPA) in 2024. Against these backgrounds, we have designed this trial to investigate whether the Firesorb BRS is non-inferior to the drug-eluting stent in terms of the Device-Oriented Composite Endpoint (DoCE) in patients undergoing percutaneous coronary intervention for de novo lesions.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 6 Jun 2025
- Start date
- 20 Dec 2025
- Primary completion date
- 20 Dec 2030
- Lead sponsor
- Xijing Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07022587
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 20 Dec 2025 to the primary completion date, 20 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received any stent implantation in the target vessel within one year
Other illness
- Known non-adherence to antiplatelet therapy or not suitable for long-term antiplatelet therapy due to high bleeding risk
- Patients who are allergic to heparin, poly L-lactic acid (PLLA), sirolimus, antiplatelet drugs, or contrast
Age
- Age \< 18 years, or \> 75 years
Other
- Patient is a woman who is pregnant or nursing
- Patients required long-term oral anticoagulation
- Currently participating in another trial and not yet at its primary endpoint
- Patients whose life expectancy is less than 3 years
- Cardiogenic shock
Who the study is looking for
- Clinical inclusion criteria
- Patients with an indication for PCI due to acute or chronic coronary syndrome
- 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
- De novo lesion(s)
- Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)
- Target lesion is NOT
- Severely calcified
- In-stent restenosis
- Diffused lesion requiring stent overlapping or more than one stent
- 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
- Bifurcation requiring two stents or involving a side branch that is ≥ 2.5 mm in diameter
- Located in the target vessel with severe tortuosity
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.