Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXijing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
De novo lesion(s)
Target vessel diameter of ≥ 2.5 mm to ≤ 4.00 mm, target lesion length ≤ 25 mm (visual estimation)
Disqualifiers
Age < 18 years, or > 75 years
Patient is a woman who is pregnant or nursing
Patients who have received any stent implantation in the target vessel within one year
Patients required long-term oral anticoagulation
Trial design
Design model
Parallel
Treatments tested in this trial
Sirolimus-eluting bioresorbable scaffolds
DeviceThe Firesorb BRS (MicroPort Medical, Shanghai, China) is a balloon-expandable scaffold with a highly crystallized PLLA backbone, abluminally coated with a poly(D, L-lactide) (PDLLA) matrix incorporating sirolimus (4 μg/mm) through highly accurate and precise point spraying techniques. The scaffold thickness is 100 μm for devices with diameters of 2.5 and 2.75 mm, and 125 μm for those ranging from 3.0 to 4.0 mm in diameter. There are two radiopaque markers at each end of the scaffold, which can identify the position of the stent under X-ray monitoring and help to accurately locate the scaffold.
Sirolimus-eluting stents
DeviceThe Firehawk™ stent (MicroPort Medical, Shanghai, China) is a third-generation balloon-expandable L605 cobalt chromium stent with abluminal grooves containing a biodegradable polymer, which provides controlled release of the anti-proliferative medicinal substance sirolimus. The polymer is biodegradable, leaving only the metallic stent as a permanent implant. The stent is mounted on a rapid exchange delivery catheter system. The unique abluminal grooves are scored at the outer surface of the struts (total strut thickness: 86 μm), with an average sirolimus dosage of 3 µg/mm stent lengths.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Bioresorbable scaffold (BRS)Experimental treatment 1 intervention
Group B: Drug-eluting stents (DES)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
DoCE is a composite clinical endpoint of cardiovascular death, target vessel myocardial infarction (TV-MI), and clinically and physiologically indicated target lesion revascularization (CPI-TLR).
Time frame
36 monthsSecondary outcomes
1
Cumulative event rate of Device-oriented Composite Endpoint (DoCE)
Rates of the DoCE beside the time point of primary endpoint
Time frame
1, 12, and 60 months2
Cumulative event rate of Patient-oriented composite endpoint (PoCE)
PoCE is defined as a composite endpoint including all-cause death, stroke, myocardial infarction, and revascularization
Time frame
1, 12, 36, and 60 months3
Cumulative event rate of Target vessel failure (TVF)
TVF is defined as a composite endpoint including cardiovascular death, TV-MI and clinically and physiologically target vessel revascularization
Time frame
1, 12, 36, and 60 months4
Cumulative event rate of All-cause death
Individual components of PoCE
Time frame
1, 12, 36, and 60 monthsSponsors and contacts
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Source ClinicalTrials.gov