Clinical trial NCT02305472: NeoVas Bioresorbable Coronary Scaffold Registry 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 Single Arm Registry Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: NeoVas
Bioresorbable Coronary Scaffold
Sirolimus
Registry Trial
Lead sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 825
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 Bioresorbable Coronary Scaffold Registry Trial is a prospective, multi-center, single arm registry trial based on the NeoVas FIM study which verified the safety and effectiveness of NeoVas initially. This study is to evaluate the safety and effectiveness of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.

Detailed description: Approximately 825 subjects will be enrolled and receive NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. The primary endpoint is target lesion failure(TLF) at 1 year follow-up.

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.
* Patients with one or two de novo lesions located in different epicardial vessels.
* 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(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 7 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.

Primary outcomes:
measure: Target lesion failure
timeFrame: 1 year
Secondary outcomes:
measure: Device Success
timeFrame: intraoperative
measure: Procedural Success
timeFrame: At time of procedure up to 7 days in hospital
measure: Target lesion failure
timeFrame: 30days, 3,6,9 months and 2,3,4,5 years
measure: Patient oriented composite endpoint
timeFrame: 30days, 3,6,9 months and 1,2,3,4,5 years
measure: Ischemia-driven Target Lesion Revascularization (iTLR)
timeFrame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
measure: Ischemia-driven Target Vessel Revascularization (iTVR)
timeFrame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
measure: All coronary revascularization (PCI and CABG)
timeFrame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
measure: Scaffold thrombosis
timeFrame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
measure: Percentage of patients who experienced angina
timeFrame: 30days, 3,6,9 months and 1, 2, 3, 4, 5 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: General Hospital of Armed Police Forces
state: Beijing
city: Beijing
country: China
facility: Aerospace Center Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Shijiazhuang
country: China
facility: Bethune Peace Hospital of PLA
state: Hebei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan General Hospital of Guangzhou Military
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The general hospital of Shenyang military region
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People'S Hospital of Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
city: Xi'an
country: China
facility: Xijing Hospital, the Fourth Military Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'An Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Military General Hospital
state: Sichuan
city: Tianjin
country: China
facility: Affiliated Hospital of The Chinese People's Armed Police Forces Logistic College
state: Tianjin
city: Tianjin
country: China
facility: Tianjin first center hospital
state: Tianjin
city: Kunming
country: China
facility: Kunming General Hospital of Chengdu Military Region
state: Yunnan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
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
role: PRINCIPAL_INVESTIGATOR
References: