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

Lepu Medical Technology (Beijing) Co., Ltd.2 sites in 1 country31 target enrollmentJuly 2014

ConditionsCoronary Artery Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Lepu Medical Technology (Beijing) Co., Ltd.
Enrollment: 31
Locations: 2
Primary Endpoint: Target Lesion Failure(TLF)
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

September 2019

Last Updated

10 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 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

Outcomes

Primary Outcomes

Target Lesion Failure(TLF)

Time Frame: 30 days

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