Status:
UNKNOWN
NeoVas Bioresorbable Coronary Scaffold First-in-Man Study
Lead Sponsor:
Lepu Medical Technology (Beijing) Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 e...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02195414
Start Date
July 1 2014
End Date
September 1 2019
Last Update
April 11 2016
Active Locations (2)
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1
The General Hospital of Shenyang Military Region
Shenyang, Liaoning, China, 110015
2
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016