Coronary Heart Disease, Drug Eluting Stent
Conditions
Brief summary
This trial is a prospective, two center single group registration pilot trial aiming to evaluate the product safety, and provide information for the later confirmatory test design according to the results.
Detailed description
This trial is a prospective, two center single group registration pilot trial with late lumen loss in stent (LLL), mace event and target lesion failure (TLF) as the main endpoint. Subjects were followed up clinically or by telephone at 1 month, 3 months, 6 months, 9 months and 12 months, and coronary angiography was performed at the target lesion segments for 6 months to calculate lumen loss. Analyze and evaluate the collected data, preliminarily evaluate the product safety, and provide information for the later confirmatory test design according to the results.
Interventions
DEVICEAbsorbable zinc alloy drug eluting coronary stent system
Absorbable zinc alloy drug eluting coronary stent system (hereinafter referred to as stent system) consists of delivery system and drug stent (hereinafter referred to as stent) pressed on the balloon end of the delivery system
Sponsors
Shandong Rientech Medical Tech Co., Ltd.
Shandong Branden Med.Device Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* (1) General inclusion criteria * The patient must be 18-75 years old; ② The patient has evidence of ischemia (such as chest pain or functional examination such as stress test, which determines that he has stable or unstable angina pectoris or asymptomatic myocardial ischemia) and is suitable for elective PCI; * The patient must be a qualified candidate for PCI; ④ Female patients of childbearing age had no pregnancy plan for up to one year after the starting operation. Women of childbearing age must have a pregnancy test and get negative results according to the regulations of the local test center 14 days before the starting operation. * Female patients were not breast-feeding during the screening visit and had no breast-feeding plan for up to 1 year after the starting operation; ⑥ The patient agrees not to participate in other clinical trials until the end point of this trial is reached; ⑦ The patient / legally authorized representative understands the purpose and procedure of 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 by quantitative analysis is less than 30%. For patients with stable coronary heart disease, LVEF measured within 6 months before operation is effective. For patients with acute coronary syndrome (ACS), LVEF must be measured before randomization to determine whether the patients meet the conditions; * The patient has a high risk of bleeding, or has a history of bleeding tendency and coagulation disorder; Major gastrointestinal bleeding within 6 months; Severe hematuria; There are contraindications to antiplatelet preparation and anticoagulant treatment, and antithrombotic treatment cannot be carried out; * Patients have allergic / hypersensitive reactions to aspirin, clopidogrel, heparin and ticlopidine hydrochloride (platelet inhibitor); * Patients have allergies or contraindications that inhibit the device materials and degradation products (rapamycin, polyglycolide and lactide) and cannot be completely cured before treatment. * The patient is allergic to contrast medium and cannot be completely cured before treatment. * Any surgical treatment requiring general anesthesia or interruption of aspirin or P2Y12 inhibitors is planned within 365 days after operation. * The patient received target vessel PCI within 365 days before operation. If the patient has received non target vessel PCI Treatment \> 30 days before operation, the patient can still be enrolled in this trial. * Patients expected to require staged PCI of target vessels. * Acute myocardial infarction within one week; A series of clinical symptoms of the patient are consistent with new acute myocardial infarction (AMI). * During screening, the patient was determined to have arrhythmia according to any of the following criteria; Patient a needs coumarin or any other long-term oral anticoagulant; B patient may have hemodynamic instability due to arrhythmia; Patients with C had poor survival and prognosis due to arrhythmia; * The patient had severe peripheral vascular disease and could not be safely inserted with 6F sheath; * Stroke (CVA) or transient ischemic attack (TIA) occurred in the past 6 months; Intracranial hemorrhage, permanent neurological deficit, or any known intracranial lesions (such as aneurysms, arteriovenous malformations, etc.) have occurred in the past ⑭ Major surgery within six weeks; ⑮ Leukocyte count \< 4.0 \* 109cells / L and platelet count \< 100 \* 109cells / L; ⑯ Severe renal and liver dysfunction; ⑰ The life expectancy of patients is less than 12 months; ⑱ The patient is receiving immunosuppressive therapy or is known to have immunosuppressive or autoimmune diseases (such as human immunodeficiency virus infection, systemic lupus erythematosus, etc.); Note: immunotherapy does not include hormone therapy; ⑲ Patients who participate in clinical trials of other drugs or devices and fail to reach the main end point of the study; ⑳ Patients who are unable or unwilling to participate in this trial, and the researchers believe that they are not suitable to participate in this trial. 8.2 angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss | 6 months after operation | Difference between the minimum lumen diameter immediately after operation and the minimum lumen diameter 6 months after operation |
| incidence of target lumen failure(TLF) | 6 months after operation | proportion of the number of patients with cardiac death, target vessel myocardial infarction, or clinical symptom driven target vessel revascularization in the total number |
| incidence of major adverse cardiac events(MACE) | 6 months after operation | proportion of the number of patients with cardiac death, myocardial infarction or target lesion revascularization (TLR) in the total number |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of target lumen failure(TLF) | 3, 9,12 months after operation | proportion of the number of patients with cardiac death, target vessel myocardial infarction, or clinical symptom driven target vessel revascularization in the total number |
| Device success rate | in the operation | It means that the instrument can be successfully delivered to the target lesion as expected, the stent can be expanded normally, and the catheter can be successfully withdrawn to the outside of the body. |
| incidence of major adverse cardiac events(MACE) | 3, 9,12 months after operation | proportion of the number of patients with cardiac death, myocardial infarction or target lesion revascularization (TLR) in the total number |
| Operation Success Rate | 0 to 24 hours after intervention | After stent implantation, stent diameter stenosis \< 30% (visual), TIMI flow class 3, and hospitalization MACE events did not happen |
| Thrombotic events incidence | 1, 3, 6, 9 and 12 months after operation | According to ARC definition it includes deterministic thrombosis, possible thrombosis and not eliminating thrombosis; point-in-time include acute within 24h, subacute between 2 and 30 d and later period over 30 d |
Outcome results
None listed