This trial is active, not recruiting.

Condition coronary artery disease
Treatments neovas bcs, xience prime eecss
Sponsor Lepu Medical Technology (Beijing) Co.,Ltd
Start date November 2014
End date June 2016
Trial size 560 participants
Trial identifier NCT02305485, LPM-201402


The NeoVas Bioresorbable Coronary Scaffold Randomized Controlled Trial is a prospective, multi-center, randomized trial. The study compares NeoVas sirolimus-eluting bioresorbable coronary scaffold with XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) to evaluate the safety and efficacy of NeoVas in the treatment of patients with de novo coronary lesion.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
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 NeoVas Bioresorbable Coronary Scaffold
Subjects receiving NeoVas BCS
(Active Comparator)
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 XIENCE PRIME Everolimus Eluting Coronary Stent System
Subjects receiving XIENCE PRIME EECSS

Primary Outcomes

In-segment late lumen loss (LLL)
time frame: 1 year

Secondary Outcomes

Major secondary endpoint: Percentage of patients who experienced angina within 1 year
time frame: From 7 days post-procedure to 1 year
Device Success
time frame: intraoperative
Procedural Success
time frame: At time of procedure up to 7 days in hospital
Target lesion failure(TLF)
time frame: 30days, 3,6,9 months and 1,2,3,4,5 years
Ischemia-driven Target Lesion Revascularization (iTLR)
time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
Ischemia-driven Target Vessel Revascularization (iTVR)
time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
All coronary revascularization (PCI and CABG)
time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years
Scaffold thrombosis
time frame: 30days, 3,6,9 months and 1, 2, 3, 4, 5 years
Percentage of patients who experienced angina
time frame: 30days, 3,6,9 months and 2, 3, 4, 5 years
Patient oriented composite endpoint
time frame: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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. - 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(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 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, 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.

Additional Information

Official title Clinical Evaluation of a Bioresorbable Sirolimus-eluting Coronary Scaffold in the Treatment of Patients With Denovo Coronary Artery Lesion (NeoVas): Randomized Controlled Trial
Principal investigator Guosheng Fu
Description Approximately 560 subjects will be randomly enrolled at a 1:1 ratio, patients in experimental group receiving NeoVas BCS(Lepu Medical Technology (Beijing) Co.,Ltd), and subjects in control group receiving XIENCE PRIME EECSS(Abbott Vascular, Inc). Subjects will have clinical follow-up at 30, 90, 180 and 270 days and at 1,2,3,4 and 5 years. All subjects will undergo coronary angiography at 1 year post-index procedure. The primary endpoint is in-segment late lumen loss(LLL) at 1 year follow-up. 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Lepu Medical Technology (Beijing) Co.,Ltd.