Coronary atherosclerotic heart disease
Conditions
Interventions
Test group:Use the coronary rapamycin targeted eluting stent system produced by Shenzhen Shunmei Medical Co., Ltd. for treatment
control group:Use the cobalt chromium alloy everolimus eluting coronary stent system produced by Abbott Medical Devices (National Medical Device Injection 20163132140) for treatment
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subject selection criteria (must be met simultaneously): (1) Age between 18-75 years old (including upper and lower limits), male or female; (2) Indications for percutaneous coronary intervention; (3) The target lesion is a primary or in situ coronary artery stenosis, with one target lesion; (4) Up to two stents can be used in the same target lesion; (5) The length of the target lesion is =70% (or >=50% with clinical evidence of myocardial ischemia within this range); (7) Left ventricular ejection fraction (LVEF) >=40% (ultrasound or left ventricular angiography); Researchers can use LVEF measured within 6 months before surgery as a basis to determine if there is no progressive decline in cardiac function; (8) Heart function classification (NYHA) <= III; (9) Be able to understand the purpose of the experiment, voluntarily participate and sign an informed consent form, and be willing to conduct clinical follow-up.
Exclusion criteria
Exclusion criteria: Exclusion criteria for subjects (meeting any of the following criteria is considered exclusion): (1) Acute myocardial infarction occurred within one month; (2) Within 1 year, any stent has been implanted into the target vessel, or there is a plan to undergo interventional treatment again within 6 months, or non target vessel PCI treatment has been received within 30 days before surgery; (3) Acute or chronic renal insufficiency (defined as serum creatinine>221 µ mol/L); (4) There is a high risk of bleeding or a history of bleeding tendency and coagulation disorders; (5) History of significant gastrointestinal bleeding or ulcers within 6 months prior to surgery, with contraindications to antiplatelet and anticoagulant therapy; (6) Within 6 months prior to surgery, there has been a stroke or transient ischemic attack (TIA), or past intracranial hemorrhage, or permanent neurological deficits, or any known intracranial lesions (such as aneurysms, arteriovenous malformations, etc.); (7) Known allergies to aspirin, clopidogrel, ticagrelor, heparin, contrast agents, rapamycin, zolpidem, polylactic acid polymers, and metals; (8) Due to the need for chemotherapy for tumors; (9) Aspirin and clopidogrel need to be discontinued within six months; (10) Pregnant or planned pregnant women and lactating women; (11) Life expectancy is less than 1 year; (12) Participate in clinical trials of other drugs or medical devices without being excluded from the group; (13) The researcher judged poor compliance and inability to complete the experiment as required; (14) The target lesion is thrombotic lesion; (15) The target lesions are chronic completely occlusive lesions, severe calcified lesions (determined by researchers to significantly increase the difficulty of stent implantation), or severe twisted lesions (determined by researchers to significantly increase the difficulty of stent implantation); (16) The target lesion involves bifurcation lesions, with branch vessel diameter >= 2.5mm, branch diameter stenosis degree >= 50%, and branches requiring the use of protective guide wires or pre dilation; (17) The target lesion is bridging vascular disease; (18) The target lesion is restenosis within the stent; (19) The target vessel has undergone stent therapy and the target lesion is located within 5mm proximal to the previously treated lesion; (20) Other situations that clinical trial researchers consider inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late intraluminal luminal loss (LLL) 9 months after stent implantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate success rate of postoperative instruments;Immediate surgical success rate after surgery;The incidence of target lesion failure (TLF) at 1, 6, 9, and 12 months after surgery;Secondary endpoint of vascular angiography 9 months after surgery;The incidence of target lesion revascularization (TLR) at 1, 6, 9, and 12 months after surgery;The incidence of target vessel revascularization (TVR) at 1, 6, 9, and 12 months after surgery;The incidence of stent thrombosis at 1, 6, 9, and 12 months after surgery;Performance evaluation of instrument delivery system; | — |
Countries
China
Contacts
Public ContactYang Junqing
Guangdong Provincial People's Hospital
Outcome results
None listed