Clinical trial NCT02195414: NeoVas Bioresorbable Coronary Scaffold First-in-Man Study
Official title: Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With de Novo Coronary Artery Lesion (NeoVas): a First-in-Man Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: NeoVas
Bioresorbable scaffold
Sirolimus
First-in-Man
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 \<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

Primary outcomes:
measure: Target Lesion Failure(TLF)
timeFrame: 30 days
Secondary outcomes:
measure: Target Lesion Failure
timeFrame: 6 months
measure: Target Lesion Failure
timeFrame: 1 year
measure: Target Lesion Failure
timeFrame: 2 years
measure: Target Lesion Failure
timeFrame: 3 years
measure: Target Lesion Failure
timeFrame: 4 years
measure: Target Lesion Failure
timeFrame: 5 years
measure: Patient Oriented Composite Endpoint
timeFrame: 30 days
measure: Patient Oriented Composite Endpoint
timeFrame: 6 months
measure: Patient Oriented Composite Endpoint
timeFrame: 1 year
measure: Patient Oriented Composite Endpoint
timeFrame: 2 years
measure: Patient Oriented Composite Endpoint
timeFrame: 3 years
measure: Patient Oriented Composite Endpoint
timeFrame: 4 years
measure: Patient Oriented Composite Endpoint
timeFrame: 5 years
measure: Acute Success (Clinical Device and Clinical Procedure)
timeFrame: acute
measure: Scaffold Thrombosis
timeFrame: 30days
measure: Scaffold Thrombosis
timeFrame: 6 months
measure: Scaffold Thrombosis
timeFrame: 1 year
measure: Scaffold Thrombosis
timeFrame: 2 years
measure: Scaffold Thrombosis
timeFrame: 3 years
measure: Scaffold Thrombosis
timeFrame: 4 years
measure: Scaffold Thrombosis
timeFrame: 5 years
measure: Angiographic Endpoint
timeFrame: 6 months
measure: Angiographic Endpoint
timeFrame: 2 years
measure: Angiographic Endpoint
timeFrame: 5 years
measure: OCT Endpoint
timeFrame: 6 months
measure: OCT Endpoint
timeFrame: 2 years
measure: OCT Endpoint
timeFrame: 5 years
measure: IVUS Endpoint
timeFrame: 6 months
measure: IVUS Endpoint
timeFrame: 2 years
measure: IVUS Endpoint
timeFrame: 5 years
measure: MSCT Endpoint
timeFrame: 1 year
measure: MSCT Endpoint
timeFrame: 3 years
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Region
state: Liaoning
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The general hospital of Shenyang military region
name: Yaling Han, MD
role: STUDY_CHAIR
affiliation: Sir Run Run Shaw Hospital
name: Guosheng Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Fuwai hospital, National center for cardiovascular diseases China
name: Bo Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Yao-Jun Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: