Clinical trial NCT07022587: Bioresorbable Sirolimus-eluting scaﬀold in de Novo Coronary Artery Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: De Novo Stenosis
Coronary Artery Disease
Keywords: bioresorbable vascular scaffold
drug-eluting stent
de novo stenosis
percutaneous coronary intervention
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 36 months
Secondary outcomes:
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 1, 12, and 60 months
measure: Patient-oriented composite endpoint (PoCE)
timeFrame: 1, 12, 36, and 60 months
measure: Target vessel failure (TVF)
timeFrame: 1, 12, 36, and 60 months
measure: All-cause death
timeFrame: 1, 12, 36, and 60 months
measure: Cardiovascular death
timeFrame: 1, 12, 36, and 60 months
measure: Stroke
timeFrame: 1, 12, 36, and 60 months
measure: Myocardial infarction
timeFrame: 1, 12, 36, and 60 months
measure: Target vessel myocardial infarction (TV-MI)
timeFrame: 1, 12, 36, and 60 months
measure: Revascularization
timeFrame: 1, 12, 36, and 60 months
measure: Clinically and physiologically indicated target vessel revascularization
timeFrame: 1, 12, 36, and 60 months
measure: Clinically and physiologically indicated target lesion revascularization (CPI-TLR)
timeFrame: 1, 12, 36, and 60 months
measure: Definite/Probable scaffold/stent thrombosis
timeFrame: 1, 12, 36, and 60 months
measure: BARC defined type 3 or 5 bleeding events
timeFrame: 1, 12, 36, and 60 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: National University of Ireland, Galway
name: Patrick Serruys, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: National University of Ireland, Galway
name: Yoshinobu Onuma, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, M.D., Ph.D.
role: STUDY_CHAIR
References: