Study on Absorbable Zinc Alloy Drug Eluting Coronary Stent System

Inclusion Criteria:

• (1) General inclusion criteria
• The patient must be 18-75 years old; ② The patient has evidence of ischemia (suchas chest pain or functional examination such as stress test, which determinesthat he has stable or unstable angina pectoris or asymptomatic myocardialischemia) and is suitable for elective PCI;
• The patient must be a qualified candidate for PCI; ④ Female patients ofchildbearing age had no pregnancy plan for up to one year after the startingoperation. Women of childbearing age must have a pregnancy test and getnegative results according to the regulations of the local test center 14days before the starting operation.
• Female patients were not breast-feeding during the screening visit andhad no breast-feeding plan for up to 1 year after the startingoperation; ⑥ The patient agrees not to participate in other clinicaltrials until the end point of this trial is reached; ⑦ The patient /legally authorized representative understands the purpose and procedureof the test and voluntarily signs the informed consent form;

Exclusion Criteria:

• ① Cardiogenic shock;
• It is known that the left ventricular ejection fraction (LVEF) measured byquantitative analysis is less than 30%. For patients with stable coronary heartdisease, LVEF measured within 6 months before operation is effective. Forpatients with acute coronary syndrome (ACS), LVEF must be measured beforerandomization to determine whether the patients meet the conditions;
• The patient has a high risk of bleeding, or has a history of bleedingtendency and coagulation disorder; Major gastrointestinal bleeding within 6months; Severe hematuria; There are contraindications to antiplateletpreparation and anticoagulant treatment, and antithrombotic treatment cannotbe carried out;
• Patients have allergic / hypersensitive reactions to aspirin,clopidogrel, heparin and ticlopidine hydrochloride (plateletinhibitor);
• Patients have allergies or contraindications that inhibit thedevice materials and degradation products (rapamycin,polyglycolide and lactide) and cannot be completely cured beforetreatment.
• The patient is allergic to contrast medium and cannot becompletely cured before treatment.
• Any surgical treatment requiring general anesthesia orinterruption of aspirin or P2Y12 inhibitors is plannedwithin 365 days after operation.
• The patient received target vessel PCI within 365days before operation. If the patient has receivednon target vessel PCI Treatment > 30 days beforeoperation, the patient can still be enrolled inthis trial.
• Patients expected to require staged PCI oftarget vessels.
• Acute myocardial infarction within oneweek; A series of clinical symptoms ofthe patient are consistent with new acutemyocardial infarction (AMI).
• During screening, the patient wasdetermined to have arrhythmiaaccording to any of the followingcriteria; Patient a needs coumarinor any other long-term oralanticoagulant; B patient may havehemodynamic instability due toarrhythmia; Patients with C had poorsurvival and prognosis due toarrhythmia;
• The patient had severeperipheral vascular disease andcould not be safely insertedwith 6F sheath;
• Stroke (CVA) or transientischemic attack (TIA)occurred in the past 6months; Intracranialhemorrhage, permanentneurological deficit, orany known intracraniallesions (such asaneurysms, arteriovenousmalformations, etc.) haveoccurred in the past ⑭ Major surgery within sixweeks; ⑮ Leukocyte count < 4.0 * 109cells / L and plateletcount < 100 * 109cells /L; ⑯ Severe renal and liverdysfunction; ⑰ The life expectancy ofpatients is less than 12months; ⑱ The patient is receivingimmunosuppressive therapyor is known to haveimmunosuppressive orautoimmune diseases (suchas human immunodeficiencyvirus infection, systemiclupus erythematosus,etc.); Note: immunotherapydoes not include hormonetherapy; ⑲ Patients who participatein clinical trials ofother drugs or devices andfail to reach the main endpoint of the study; ⑳ Patients who are unableor unwilling toparticipate in this trial,and the researchersbelieve that they are notsuitable to participate inthis trial.

8.2 angiographic exclusion criteria

1. The target lesion is located in the left main trunk and more than one lesion (not asingle target lesion);
2. The% ds of visual or quantitative evaluation of target lesions is less than 50%, andthe blood flow TIMI is less than grade 1.
3. The Dmax of target lesions measured by online QCA exceeds the range of 2.5mm-3.53.5mm,or the RVD measured by visual inspection exceeds the range of 2.5mm-3.53.5mm.
4. The visual length of target lesion or the length measured by online QCA is not withinthe range of ≤ 28 ≤ 28mm.
5. The target lesion of the right coronary artery (RCA) at the aortic opening (within 3mmof the aortic junction of RCA);
6. The target lesion is located within 3mm from the starting point of left anteriordescending artery (LAD) or left circumflex artery (LCX).
7. The target lesion involves bifurcation and has the following characteristics: A side branch diameter ≥ 2mm; B diameter stenosis ≥ 50%; The C lateral branch needs touse protective guide wire or the lateral branch needs to be pre expanded.
8. Anatomical structures near or within the target lesion hinder the delivery of zincalloy stents, including: A extreme reverse arch (≥ 90 °) at the proximal end of the target lesion or within thelesion; B. excessive bending of the proximal end of the target lesion or within thelesion (≥ two 45 ° angles); C moderate or severe calcification near or inside thetarget lesion.
9. The target lesion or target vessel involves myocardial bridge;
10. Angiographic images showed that the target vessel contained thrombus;
11. Before the starting operation, the target vessel has been treated with stent, and thezinc alloy stent will need to pass through the stent to reach the target lesion;
12. The target vessel has been treated with stent, and the target lesion is located within 5mm of the proximal end of the treated lesion;
13. The pre dilated balloon could not expand completely at the target lesion. Fullexpansion is based on the following criteria: A. the stenosis rate (% DS) of participating lesion diameter must be < 40% (visualinspection); B blood flow reaches timi3 (visual inspection); C no angiographiccomplications (e.g. distal embolization, collateral occlusion); D no interlayer, NHLBIgrade, d-f type; E no persistent chest pain (> 5 minutes) and no ST segment depression orelevation lasting > 5 minutes.