NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

NCT02195414 | Unknown Phase 1 Results DMC

• 1 other identifier: LPM-201401
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

NeoVas; Bioresorbable scaffold; Sirolimus; First-in-Man

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure(TLF)

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

  30 days

Secondary Outcomes (32)

• Target Lesion Failure

  6 months

• Target Lesion Failure

  1 year

• Target Lesion Failure

  2 years

• Target Lesion Failure

  3 years

• Target Lesion Failure

  4 years

Study Arms (1)

NeoVas BCS

EXPERIMENTAL

The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.

Device: NeoVas BCS

Interventions

NeoVas BCS DEVICE

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. 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.

Also known as: NeoVas bioresorbable coronary scaffold

NeoVas BCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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 which in the investigator's opinion may limit his/her ability to participate in the study
• 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

Sponsors & Collaborators

• Lepu Medical Technology (Beijing) Co., Ltd.: lead

Study Sites (2)

The General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110015, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Yaling Han, Study Chair of Clinical Trials
• Organization: The General Hospital of Shenyang Military Region

hanyaling@263.net

+86-024-28856123

Study Officials

• Yaling Han, MD

  The general hospital of Shenyang military region

  STUDY CHAIR

• Guosheng Fu

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Bo Xu

  Beijing Fuwai hospital, National center for cardiovascular diseases China

  PRINCIPAL INVESTIGATOR

• Yao-Jun Zhang, PhD

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 21, 2014
• Study Start: July 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2019
• Last Updated: April 11, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-03

Locations

CN (2)