Coronary artery stenosis
Conditions
Interventions
Test group (FIM):Bioresorbable coronary drug-eluting stent system (trade name: Amet AMSporTM)
Test group (RCT):Bioresorbable coronary drug-eluting stent system (trade name: Amet AMSporTM)
Control group (RCT):HELIOS drug stent system
Control group (Single arm):Bioresorbable coronary drug-eluting stent system (trade name: Amet AMSporTM)
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: FIM: General selection criteria: 1)Age between 18 and 79 years, male or non pregnant female. 2)Suitable for accepting elective PCI; 3) The subjects must be qualified candidates for CABG surgery; 4) The subjects agree not to participate in other clinical trials before reaching the endpoint of this trial; 5) Subjects/legally authorized representatives/guardians who understand the purpose and procedures of the trial and voluntarily sign informed consent forms, and are willing to undergo invasive imaging follow-up. The general selection criteria of RCT and single arm are the same as the FIM . Angiography inclusion criteria of FIM: 1) Single target lesion on a single target vessel; 2) The target lesion must be located in the autologous coronary artery, with a visual or quantitative evaluation of% DS >= 50%,= 1 grade; 3) The Dmax measured by online QCA of the target lesion is >=3.0mm and = 3.0mm and =70% (or = 50% with clinical evidence of myocardial ischemia in this range), and= grade 1; 3) Target lesion length <= 28mm (visual inspection); The target lesion vessel diameter is between 2.5mm and 4.0mm; Each target lesion can be completely covered by a stent.
Exclusion criteria
Exclusion criteria: FIM: General exclusion criteria: 1) Cardiogenic shock; 2) Within 7 days prior to surgery, there was an acute myocardial infarction (AMI) and creatine kinase isoenzyme (CK-MB) had not yet returned to the normal range (ULN) at the time of surgery; 3) Received target vessel PCI treatment within 365 days prior to surgery, or received non target vessel PCI treatment within 30 days prior to surgery; It is expected that staged PCI treatment will be required for the target vessel; 4) Severe heart failure (NYHA III or above) or left ventricular ejection fraction (LVEF)176 µ mol/L; or currently undergoing hemodialysis treatment; 6) Patients with bleeding tendency, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, history of ischemic stroke within six months, contraindications to antiplatelet and anticoagulant therapy, and inability to undergo antithrombotic therapy; 7) Individuals allergic to aspirin, clopidogrel, heparin, contrast agents, polylactic acid polymers, and rapamycin; 8) Those who have participated in clinical trials of other drugs or medical devices before being selected but have not reached the primary study endpoint time limit; 9) Researchers have determined that patients have poor compliance and are unable to complete clinical trials as required; 10) Patients undergoing substantial organ transplantation, or those preparing to receive organ transplantation; 11) Unstable arrhythmia, such as high-risk ventricular premature beats and ventricular tachycardia; 12) Due to the need for chemotherapy for tumors; 13) Having immunosuppressive or autoimmune diseases, planning or currently undergoing immunosuppressive therapy; 14) Planned or currently undergoing long-term anticoagulant therapy, such as heparin, warfarin, etc; 15) Patients who have scheduled surgical procedures within six months and need to discontinue aspirin and clopidogrel; 16) The blood routine test indicates that the platelet count is below 100 × 109/L or above 700 × 109/L, and the white blood cell count is below 3 × 109/L; 17) The patient has diffuse peripheral vascular disease and cannot use a 6F catheter. Exclusion criteria for angiography: 1) The target lesion is located in the left main; 2) The target lesion of the right coronary artery (RCA) located at the aorto- ostial (within 3mm of the RCA aortic junction); 3) The target lesion is located within 3mm of the origin of the left anterior descending artery (LAD) or left circumflex artery (LCX); 4) The target lesion involves bifurcation and has the following characteristics: A. Side branch diameter >= 2mm; B. Diameter stenosis >= 50%; C. Side branches require the use of protective guide wires or require pre-expansion. 5) The anatomical structures near or within the target lesion can hinder the delivery of the bioresorbable stent, including: A. Extreme arching (>= 90 °) near or within the target lesion; B. Excessive bending (>= two 45 ° angles) near or within the target lesion; C. Moderate or severe calcification near or inside the target lesion. 6) Dealing with target lesions involves myocardial bridges; 7) Angiography images show the presence of thrombus in the target blood vessel; 8) Prior to the initial surgery, the target vessel had undergone stent treatment, and the bioresorbable stent would need to be implanted to reach the target lesion; 9) The target vessel has undergone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss within the stent and lesion segment 180 days after surgery(FIM);30 day target lesion failure (TLF) rates(FIM);180 day target lesion failure (TLF) rates;Late stage lumen loss within stent segment 365 days after surgery(RCT);Incidence of target lesion failure (TLF) 365 days after surgery (Single arm); | — |
Secondary
| Measure | Time frame |
|---|---|
| Instant Success Rate (FIM/RCT/Single arm);Clinical evaluation: 30 days after surgery (FIM/RCT/Single arm);Clinical evaluation: 90 days after surgery (FIM);Clinical evaluation: 180 days after surgery (FIM/RCT/Single arm);Post operative analysis of all vascular imaging endpoints (FIM/RCT); 180 days after surgery operative analysis of all vascular imaging endpoints (FIM);Clinical evaluation: 2-year postoperative randomized controlled trial (RCT);Clinical evaluation: 3-year postoperative randomized controlled trial (RCT);Clinical evaluation: 365 days postoperatively (RCT/Single arm);365 days after surgery operative analysis of all vascular imaging endpoints (RCT); | — |
Countries
China
Contacts
Public ContactHuo Yong
Peking University First Hospital
Outcome results
None listed