Status:
UNKNOWN
OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS)
Lead Sponsor:
Xuzhou Third People's Hospital
Collaborating Sponsors:
Shandong Jiwei Medical Products Co., Ltd
Conditions:
Unstable Anginas
Non ST Segment Elevation Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a prospective study of a new generation of drug-eluting stent in the treatment of non ST elevation acute coronary syndrome (NSTE-ACS). The purpose of this study was to evaluate the extent of e...
Detailed Description
This study is a prospective, randomized controlled clinical trial, which will adopt the central randomized method based on computer system. When a patient signs the informed consent form and meets the...
Eligibility Criteria
Inclusion
- Male or non pregnant female aged 18-80;
- Patients with unstable angina or acute non ST segment elevation myocardial infarction have been diagnosed clinically;
- The target lesions are primary and in situ coronary lesions. If there are multiple target lesions, they must be located in different epicardial vessels;
- The total length of each target lesion is ≤ 40mm, and the diameter of the target vessel is 2.5mm-4.5mm (visual method);
- The stenosis degree of target lesion ≥ 70% or the stenosis degree of target lesion with evidence of myocardial ischemia ≥ 50% (visual method);
- Each patient is allowed to implant at most 3 homostents (except for salvage implantation of additional stents), and each target lesion is allowed to implant at most 2 homostents;
- Patients with indication of coronary artery bypass surgery;
- Patients who can understand the purpose of this trial, voluntarily participate in and sign the informed consent, have good compliance after discharge, take medicine on time, and are willing to receive optical coherence tomography (OCT) examination and clinical follow-up.
Exclusion
- Any acute ST segment elevation myocardial infarction within 1 month;
- Chronic total occlusion (preoperative Timi Grade 0 blood flow), severe left main coronary artery disease, long disease (disease length \> 40mm), bifurcated disease with double stenting, diameter of disease vessel \> 4.5mm, incomplete optical coherence tomography (OCT) at the lesion site or the disease is not suitable for OCT imaging, bypass vessel disease, visible thrombus in the target vessel, concurrent infection or other inflammatory diseases;
- Severe calcification and tortuosity can not be successfully pre dilated, which is not suitable for stent delivery and expansion;
- Restenosis in stent;
- Patients who had implanted any brand of stent in one year, those who had the possibility of reoperation in one year, and those who had implanted stent for more than one year;
- Hemodynamics or respiratory and circulatory instability have been demonstrated, such as cardiogenic shock, severe heart failure (NYHA III and above) or left ventricular ejection fraction \< 40% (ultrasound or left ventriculography);
- The renal function was damaged before operation: EGFR \< 60ml / (min · 1.73m2) or serum creatinine \> 2.5mg/dl (178 μ mol / L);
- Patients with bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or subretinal hemorrhage, history of stroke within half a year, contraindications of antiplatelet agents and anticoagulants cannot receive anticoagulant treatment;
- Allergic to aspirin, clopidogrel or tegrelol, statins, heparin, contrast agents, polymers, zoltamox and metals;
- The life expectancy of patients is less than 12 months;
- Those who have participated in clinical trials of other drugs or medical devices before being selected but failed to reach the time limit of main research end point;
- The researcher judges that the patient's compliance is poor and is unable to complete the study as required, unwilling or unable to provide written informed consent;
- Heart transplant patients;
- There are unstable arrhythmias, such as high-risk ventricular premature beats and ventricular tachycardia;
- Because the tumor needs chemotherapy within 30 days;
- Have immunosuppressive, autoimmune diseases, plan or are receiving immunosuppressive treatment;
- Patients who need to stop aspirin, clopidogrel or tegrilol due to selective surgery within half a year;
- Blood routine examination showed that platelet count was lower than 100 × 10∧9/ L, or higher than 700 × 10∧9 / L, leukocyte was lower than 3 × 10∧9 / L, and liver diseases (such as hepatitis) were diagnosed or suspected;
- The patient had diffuse peripheral vascular disease and could not use 6F catheter.
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04375319
Start Date
October 28 2019
End Date
December 31 2023
Last Update
May 5 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Xuzhou Third People's Hospital
Xuzhou, Jiangsu, China, 221000
2
Peixian Guotai hospital
Xuzhou, Jiangsu, China, 221600