neovas bioresorbable coronary scaffold first-in-man study

Conditions: Coronary Artery Disease

Summary: the neovas first-in-man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. the hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of neovas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.

the primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (tlf) at 1 month follow up. at 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include tlf (its individual components), patient-oriented cardiac event (all cause death, all mi, and all revascularization) target vessel revascularization, scaffold thrombosis.

Eligibility criteria:
inclusion criteria: * age must be between 18 and 75 years, men or unpregnant women * patient must have evidence of myocardial ischemia (e.g., stable angina, unstable angina) * total number of target lesion =1 per patient * target lesion must be ≤ 20mm in length (visual estimation) and 2.75 to 3.75 mm in diameter（online qca） * 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 * patient must be an acceptable candidate for coronary artery bypass graft. * patient is able to verbally confirm understanding of risks, benefits and treatment of receiving the neovas bioresorbable coronary scaffold and he/she or his/her legally authorized representative provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate ethics committee of the respective clinical site. 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, fork and bridge vessel lesions of branch vessels whose diameter ≥2.0mm(branch opening stenosis exceeds 40% or need balloon expansion); 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 6 months after the study procedure; target vessels that has been planted stents over a year. * severe heart failure(over nyha iii grade ), or left ventricular ejection fraction(lvef)\< 40%( supersonic inspection or left ventricular radiography ) * known renal insufficiency (e.g., egfr \<60 ml/min, 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 can not bear anticoagulation treatment * patient has a known hypersensitivity or contraindication to aspirin, clopidogrel, 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 which in the investigator's opinion may limit his/her ability to participate in the study * 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, coumadin) * elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel * platelet count \ 700,000 cells/mm3, a wbc of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) * patient has extensive peripheral vascular disease that precludes safe 6 french sheath insertion

Keywords: neovas bioresorbable scaffold sirolimus first-in-man