NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial
NCT ID: NCT02305485
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
560 participants
INTERVENTIONAL
2014-11-30
2020-06-30
Brief Summary
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Detailed Description
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Among the RCT study, a subgroup study is designed to evaluate the functional recovery of vasomotion before and after the complete degradation of the NeoVas Bioresorbable Coronary Scaffold with the aid of angiography, OCT and FFR. The subgroup study will be performed in two centers and 160 subjects will be enrolled on a 1:1 randomization basis. Subjects will receive angiography and OCT examination before procedure, and will receive angiography, OCT and FFR after procedure and at 1, 3 years follow-up.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NeoVas
The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA- based polymer scaffold and contains the antiproliferative drug sirolimus.
Intervention: Device: NeoVas BCS
NeoVas BCS
Subjects receiving NeoVas BCS
XIENCE PRIME
XIENCE PRIME Everolimus Eluting Coronary Stent System is a balloon expandable metallic platform stent manufactured from a flexible cobalt chromium alloy with a multicellular design and coated with a thin nonadhesive, durable, biocompatible acrylic, and fluorinated everolimus-releasing copolymer. Intervention: Device: XIENCE PRIME EECSS
XIENCE PRIME EECSS
Subjects receiving XIENCE PRIME EECSS
Interventions
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NeoVas BCS
Subjects receiving NeoVas BCS
XIENCE PRIME EECSS
Subjects receiving XIENCE PRIME EECSS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* Total number of target lesion =1 per patient.
* Target lesion must be≤20mm in length and 2.50 to 3.75 mm in diameter(visual estimation).
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Lepu Medical Technology (Beijing) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yaling Han, MD
Role: STUDY_CHAIR
The general hospital of Shenyang military region
Guosheng Fu
Role: PRINCIPAL_INVESTIGATOR
Sir Run Run Shaw Hospital
Bo Xu
Role: PRINCIPAL_INVESTIGATOR
Beijing Fuwai hospital, National center for cardiovascular diseases China
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, China
Aerospace Center Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Bethune Peace Hospital of PLA
Shijiazhuang, Hebei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The general hospital of Shenyang military region
Shenyang, Liaoning, China
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Tenth People'S Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Xijing Hospital, the Fourth Military Medical University
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi’an, Shanxi, China
Chengdu Military General Hospital
Chengdu, Sichuan, China
Affiliated Hospital of The Chinese People's Armed Police Forces Logistic College
Tianjin, Tianjin Municipality, China
Tianjin first center hospital
Tianjin, Tianjin Municipality, China
Kunming General Hospital of Chengdu Military Region
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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Xu K, Fu G, Wang X, Song L, Tao L, Li L, Hou Y, Su X, Fang Q, Chen L, Liu H, Wang B, Yuan Z, Gao C, Zhou S, Guan C, Li Y, Han Y, Stone GW; NeoVas Randomized Controlled Trial Investigators. 5-Year Outcomes With a Novel Coronary Sirolimus-Eluting Bioresorbable Scaffold: The NeoVas Randomized Trial. JACC Cardiovasc Interv. 2025 Sep 8;18(17):2107-2115. doi: 10.1016/j.jcin.2025.06.036.
Han Y, Xu B, Fu G, Wang X, Xu K, Jin C, Tao L, Li L, Hou Y, Su X, Fang Q, Chen L, Liu H, Wang B, Yuan Z, Gao C, Zhou S, Sun Z, Zhao Y, Guan C, Stone GW; NeoVas Randomized Controlled Trial Investigators. A Randomized Trial Comparing the NeoVas Sirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents. JACC Cardiovasc Interv. 2018 Feb 12;11(3):260-272. doi: 10.1016/j.jcin.2017.09.037.
Other Identifiers
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LPM-201402
Identifier Type: -
Identifier Source: org_study_id