Acute Myocardial Infarction
Conditions
Interventions
treatment group:Bioresorbable Rapamycin-Eluting Coronary Stent System
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for study participants (must be met simultaneously): 1) Age >=18 years and 50% before pre-dilation; • The target lesion must have a Dmax >=2.75 mm and =2.75 mm and <=3.75 mm; • The target lesion length must be <=24 mm as visually estimated or measured by online QCA; 4) Able to understand the study objectives, voluntarily participate, and sign the Informed Consent Form, and be willing to undergo clinical follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria for study participants (exclusion applies if any of the following criteria is met): 1) Individuals with allergic reactions to poly-L-lactic acid (PLLA), poly-DL-lactic acid (PDLLA), rapamycin and its derivatives, platinum, or aliphatic polyester copolymers or blends; 2) Individuals with severe reactions to contrast agents or those who cannot use the medication; 3) Individuals with contraindications to antiplatelet therapy, such as bleeding tendencies, blood disorders, active peptic ulcers, or recent cerebrovascular accidents; 4) Individuals with a high risk of bleeding, or a history of bleeding tendencies and coagulation disorders; 5) Individuals with recent gastric bleeding or active gastric ulcers; 6) Individuals with contraindications to antiplatelet or anticoagulant therapy; 7) Individuals with severe liver or kidney dysfunction; 8) Pregnant or breastfeeding female patients; 9) Any other conditions deemed by the clinical trial investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major adverse cardiac events (MACE) at 12 months after stent implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate device success rate;Immediate procedural success rate;Secondary angiographic endpoints at 12 months postoperatively;Stent thrombosis at 12 months postoperatively;5) Incidence of target lesion failure (TLF) at 1, 6 and 12 months postoperatively;Incidence of target lesion revascularization (TLR) at 1, 6 and 12 months postoperatively;Incidence of target vessel revascularization (TVR) at 1, 6 and 12 months postoperatively;Incidence of major adverse cardiac events (MACE) at 1 and 6 months postoperatively; | — |
Countries
China
Contacts
Public ContactYuguo Chen ;Chuanbao Li
Qilu Hospital of Shandong University
Outcome results
None listed