Bioresorbable sirolimus‑coated scaffold for new coronary artery blockages

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xijing Hospital
  Xi'an, Shannxi, China Recruiting

Study contacts

• Study coordinator: Chao Gao, M.D., Ph.D.
• Email: woshigaochao@gmail.com
• Phone: +86-18629551066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.