NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

Phase 1

Conditions: Coronary Artery Disease

Interventions: Device: NeoVas BCS

Registration Number: NCT02195414

Lead Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: UNKNOWN

Sex: All

Target Recruitment: 31

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 <100,000 cells/mm3 or >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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NeoVas BCS	NeoVas BCS	The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure(TLF)	30 days	Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Target Lesion Failure	5 years
Acute Success (Clinical Device and Clinical Procedure)	acute	Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable). Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.
Scaffold Thrombosis	5 years
OCT Endpoint	5 years
MSCT Endpoint	3 years
Patient Oriented Composite Endpoint	5 years
Angiographic Endpoint	5 years
IVUS Endpoint	5 years

Trial Locations

Locations (2): The General Hospital of Shenyang Military Region
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Shenyang, Liaoning, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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Hangzhou, Zhejiang, China