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Bioresorbable Sirolimus-eluting scaffold in de Novo Coronary Artery Lesions

RecruitingNAAges 18 Years - 75 YearsAllXijing Hospital
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In plain words

What the trial is, and whether it could suit you

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 th

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Sirolimus-eluting bioresorbable scaffolds
  • Sirolimus-eluting stents
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Where

1 site
Xijing Hospital
Xi'an, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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