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

Lepu Medical Technology (Beijing) Co., Ltd.27 sites in 1 country825 target enrollmentNovember 2014

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Enrollment: 825
Locations: 27
Primary Endpoint: Target lesion failure
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

September 2020

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lepu Medical Technology (Beijing) Co., Ltd.

Responsible Party

Sponsor

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 ≥
•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.

Outcomes

Primary Outcomes

Target lesion failure

Time Frame: 1 year

Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

Secondary Outcomes

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