NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring NeoVas, Bioresorbable Coronary Scaffold, Sirolimus, Randomized Controlled Trial
Eligibility Criteria
Inclusion Criteria:
- Age must be 18-75 years, men or unpregnant women.
- Patient must have evidence of myocardial ischemia, suitable for elective PCI. Subjects with stable angina or silent ischemia and <70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve(FFR) must be done and indicative of ischemia.
- Total number of target lesion =1 per patient.
- Target lesion must be≤20mm in length and 2.50 to 3.75 mm in diameter(visual estimation).
- Target lesion is with a visually estimated stenosis of ≥70%(or≥50% and evidence of myocardial ischemia) with a TIMI flow of ≥1.
- The target lesion can be covered by one scaffold(except the rescue scaffold).
- Patient must be an acceptable candidate for coronary artery bypass graft.
- Patient or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
Exclusion Criteria:
- Patients has had a known diagnosis of acute myocardial infarction(AMI) within 30 days preceding the procedure; CK and CK-MB have not returned within normal limits at the time of procedure
- Chronic total occlusion lesions (TIMI 0 grade blood flow prior to implantation), left trunk vessel lesion, ostial lesion, multi-branch lesions needing treated, bifurcation lesion (diameter ≥2.0mm, branch opening stenosis exceeds 50% or need balloon expansion) and bridge vessel lesions; there is thrombus visible in the target blood vessels.
- Severe calcified lesions and twisted lesions which cannot be pre-expanded, and lesions unsuitable for delivering and expanding stents.
- In-stent restenosis lesion.
- Patient has undergone previous stenting anywhere within the target vessel(s) within the previous 12 months, or will require stenting within the target vessel(s) within 1 year after the study procedure; target vessels that has been implanted with stents.
- Severe heart failure(over NYHA III grade ), or left ventricular ejection fraction(LVEF)<40%( supersonic inspection or left ventricular radiography ).
- Known renal insufficiency(eGFR<60 ml/min, serum creatinine>2.5mg/dL, or subject on dialysis).
- Patients with hemorrhage tendency, an active digestive ulcer history, a cerebral hemorrhage or subarachnoid hemorrhage history, or cerebral apoplexy within half a year, and these patients who contraindicate against platelet inhibitors and anticoagulant therefore cannot bear anticoagulation treatment.
- Patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, ticagrelor or prasugrel, heparin, contrast agent, polylactic acid or sirolimus that cannot be adequately pre-medicated.
- Life expectancy < 12 months
- Patient is participating in another device or drug study that has not reached the primary endpoint of the study.
- Patient's inability to fully cooperate with the study protocol.
- Patient has a heart transplant.
- Patient has current unstable arrhythmias, such as high risk ventricular premature beat and ventricular tachycardia.
- Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
- Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease.
- Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, warfarin).
- Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin, clopidogrel, ticagrelor or prasugrel.
- Platelet count<100,000 cells/mm3 or>700,000 cells/mm3, a WBC of<3,000 cells/mm3, or documented or suspected liver disease.
- Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
Sites / Locations
- Anhui Provincial Hospital
- Beijing Anzhen Hospital, Capital Medical University
- General Hospital of Armed Police Forces
- Aerospace Center Hospital
- Fujian Medical University Union Hospital
- The First Hospital of Lanzhou University
- Nanfang Hospital Southern Medical University
- The First Affiliated Hospital of Guangxi Medical University
- Bethune Peace Hospital of PLA
- Renmin Hospital of Wuhan University
- Wuhan General Hospital of Guangzhou Military
- Xiangya Hospital Central South University
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
- Zhongda Hospital Southeast University
- Jiangsu Province Hospital
- The general hospital of Shenyang military region
- Renji Hospital Shanghai Jiaotong University School of Medicine
- Shanghai Tenth People'S Hospital of Tongji University
- Changhai Hospital of Shanghai
- Xijing Hospital, the Fourth Military Medical University
- The First Affiliated Hospital of Xi'An Jiaotong University
- Chengdu Military General Hospital
- Affiliated Hospital of The Chinese People's Armed Police Forces Logistic College
- Tianjin first center hospital
- Kunming General Hospital of Chengdu Military Region
- The First Affiliated Hospital, Zhejiang University
- Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NeoVas
XIENCE PRIME
The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA- based polymer scaffold and contains the antiproliferative drug sirolimus. Intervention: Device: NeoVas BCS
XIENCE PRIME Everolimus Eluting Coronary Stent System is a balloon expandable metallic platform stent manufactured from a flexible cobalt chromium alloy with a multicellular design and coated with a thin nonadhesive, durable, biocompatible acrylic, and fluorinated everolimus-releasing copolymer. Intervention: Device: XIENCE PRIME EECSS