Coronary Atherosclerotic Heart Disease
Conditions
Interventions
Treatment Group:XINSORB Biodegradable Coronary Rapamycin-eluting Stent System
Control Group:Tivoli Coronary Drug-eluting Stent System
Sponsors
Zhongshan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General selection criteria: 1. Patients between 18 years old to 75 years old; 2. Patients with evidence of ischemia (e.g. stable or unstable angina or asymptomatic myocardial ischemia with symptoms of ischemia) who candidates for elective PCI or evidence of asymptomatic ischemia, stable or unstable angina; 3. Patients who are qualified candidates for CABG surgery; 4. Females of childbearing age (18-49 years of age) who are confirmed not pregnant by the doctor before stent implantation. 5. Females who are not breastfeeding during the trial and will not breastfeed within 1 year after stent implantation; 6. Patients who will not participate other clinical trials before the end of the trial; 7. Patients who understand the purpose and procedure of the trial and voluntarily sign the informed consent form by themselves or the authorized representatives. Angiography selection criteria: 1. One target lesion (a single target lesion located in the epicardial vessel which meets the criteria for angiography) or two target lesions (two target lesions located in two different epicardial vessels, each with only one lesion and each lesion meets the criteria for angiography); Note 1: Epicardial vessels are the three major epicardial vessels, i.e.the left anterior descending artery (LAD) and its branches, the left circumflex artery (LCX) and its branches and the right coronary artery (RCA) and its branches; Note 2: Only one stent (except emergency stents) is implanted in each target lesion whether there are one or two target lesions, and each patient is implanted with the same stent. 2. Target lesion located in the autologous coronary arteries whose %DS are between 50% and 100% of visual or quantitative assessment, and TIMI score=1; 3. Online QCA measured Dmax between 2.75 mm and 3.5 mm or visually measured RVD between 2.75 mm and 3.5 mm; 4. Visually measured target lesion length or online QCA measured length = 24mm.
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Cardiogenic shock; 2. Left ventricular ejection fraction (LVEF) <30% by transthoracic echocardiography or intraoperative left ventricular angiography quantitative analysis.For patients with stable coronary heart disease, LVEF was measured within 6 months before surgery; 3. Patients with high risk of bleeding, or bleeding tendency, history of coagulopathy; significant gastrointestinal bleeding within 6 months; severe hematuria; contraindications for antiplatelet agents and anticoagulant therapy. 4. Patients allergic to aspirin, heparin, clopidogrel and other P2Y12 inhibitors; 5. Patients allergic to devise materials and degradation products (rapamycin, L-polylactic acid, racemic polylactic acid, lactide, lactic acid) or contraindications that could not be completely cured before treatment; 6. Patients allergic to contrast medium; 7. Patients who are going to do any surgery requiring general anesthesia or interruption of aspirin and/or P2Y12 inhibitors within 365 days after stent implantation; 8. Patients who received target-vessel PCI within 365 days prior to surgery or received non-target-vessel PCI within 30 days prior to surgery; 9. Patients requiring staged PCI for target vessels. 10. Acute myocardial infarction in one week; A series of clinical symptoms in line with the new AMI. CK and CK-MB are not returned to the normal range (ULN) within one week after acute myocardial infarction; 11. Arrhythmias diagnosed by any one of the following criteria: (1) Patients taking coumadin or any other long-term oral anticoagulation; (2) Patients who have hemodynamic instability due to arrhythmia; (3) Patients with poor prognosis due to arrhythmia; 12. Patients with severe peripheral vascular disease who cannot be treated by 6F sheath safe insertion; 13. Cerebral infarction (CVA) or transient ischemic attack (TIA) occurred in the past 6 months, intracranial hemorrhage, permanent neurological deficits or intracranial lesions, e.g. aneurysms, arteriovenous malformations; 14. Large surgery within six weeks; 15. White blood cell count <4.0 * 109 cells / L and platelet count <100 * 109 cells / L; 16. Patients who have liver dysfunction, defined as cirrhosis or Child-Pugh ? Grade B; or patients who have renal insufficiency, defined as the glomerular filtration rate (eGFR) <30ml / min / 1.73m2 or undergoing dialysis; 17. Expected life expectancy less than 24 months; 18. Patients who are receiving immunosuppressive therapy or have immunosuppressive or autoimmune diseases (such as human immunodeficiency virus infection, systemic lupus erythematosus, etc.); Note: Immunosuppressive therapy does not include hormonal therapy; 19. Patients in other drugs or equipment clinical trials did not reach the main end of the study; 20. Patients who are not willing to participate in this trial. Angiography Exclusion Criteria: 1. Target lesions in the left main coronary artery; 2. Right coronary artery (RCA) target lesion within 3 mm of the aortic opening; 3. Target lesions located within 3 mm of the left anterior descending artery (LAD) opening or left circumflex artery (LCX) opening; 4. Target lesions involving bifurcations and with the following characteristics: (1) collateral diameter = 2mm; (2) stenosis =50%; (3) collateral branches need protection wire or pre-expansion; 5. Anatomy of the target lesion hinders the delivery of XINSORB, including: (1) Extreme arch (=90 °) at or near the target lesion; (2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late Luminal Loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Target Lesion Success;Device Success;Procedural Success;Target Lesion Failure;Patient-oriented Composite; | — |
Countries
China
Contacts
Public ContactJunbo Ge
Zhongshan Hospital
Outcome results
None listed