Bioresorbable sirolimus‑coated scaffold for new coronary artery blockages

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

This tests a dissolving sirolimus‑coated coronary scaffold as an alternative to metal drug‑eluting stents for adults undergoing PCI for new (de novo) coronary narrowings.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Xijing Hospital (Academic / other)
• Locations: 1 site (Xi'an, Shannxi)
• Trial ID: NCT07022587 on ClinicalTrials.gov

What this trial studies

This interventional trial uses the latest Firesorb poly-L-lactic acid scaffold with an abluminal sirolimus coating to treat selected de novo coronary lesions during percutaneous coronary intervention. Eligible lesions are 2.5–4.0 mm in diameter and ≤25 mm long, and complex lesions such as severe calcification, in‑stent restenosis, bifurcations needing two stents, left main or ostial disease, chronic total occlusions, or severe tortuosity are excluded. Patients will receive the bioresorbable sirolimus‑eluting scaffold and undergo regular clinical and imaging follow-up to monitor vessel healing, scaffold performance, and safety outcomes. The protocol emphasizes optimized implantation technique and follow-up to detect late scaffold-related events.

Who should consider this trial

Good fit: Adults aged 18–75 with acute or chronic coronary syndrome who need PCI for a single de novo lesion sized 2.5–4.0 mm in diameter and ≤25 mm in length and who can consent and attend follow-up are ideal candidates.

Not a fit: Patients with severely calcified lesions, in‑stent restenosis, lesions requiring overlapping stents, left main/ostial/proximal major vessel ostial involvement, bifurcations requiring two stents, chronic total occlusion, severe vessel tortuosity, or age outside 18–75 are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the device could provide temporary vessel support and drug delivery while eventually dissolving, potentially lowering late complications from permanent metal stents and restoring more natural vessel function.

How similar studies have performed: Earlier bioresorbable scaffolds such as ABSORB were linked to higher late scaffold thrombosis and are not preferred in practice, while Firesorb represents a newer, thinner‑strut design but currently has limited outcome data compared with established drug‑eluting stents.

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

Where this trial is running

Xi'an, Shannxi

• Xijing Hospital — Xi'an, Shannxi, China (Recruiting)

Study contacts

• Study coordinator: Chao Gao, M.D., Ph.D.

Conditions De Novo Stenosis; Coronary Artery Disease; bioresorbable vascular scaffold; drug-eluting stent; de novo stenosis; percutaneous coronary intervention