Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions (REC-CAGEFREE Ⅳ)

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Coronary Artery Disease; De Novo Stenosis

Treatments: Device: Sirolimus-eluting bioresorbable scaffolds; Device: Sirolimus-eluting stents

Study type: Interventional

Funder types: Other

Identifiers

NCT07022587

KY20252116-C-1

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Bioresorbable scaffold (BRS)

Experimental group

Treatment:

Device: Sirolimus-eluting bioresorbable scaffolds

Drug-eluting stents (DES)

Active Comparator group

Treatment:

Device: Sirolimus-eluting stents