NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Lepu Medical Technology (Beijing) Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Lepu Medical Technology (Beijing) Co.,Ltd
ClinicalTrials.gov Identifier:
NCT02195414
First received: July 16, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: NeoVas BCS
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lepu Medical Technology (Beijing) Co.,Ltd:

Primary Outcome Measures:
  • Target lesion failure(TLF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Target lesion failure [ Time Frame: 6 months and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
    Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization.

  • Patient oriented composite endpoint [ Time Frame: 30 days, 6 months and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
    Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.

  • Acute success (clinical device and clinical procedure) [ Time Frame: acute ] [ Designated as safety issue: Yes ]

    Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable).

    Successful delivery and deployment of the Clinical Investigation scaffold at the intended target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of less than 50% of the target lesion by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In dual lesion setting both lesions must meet clinical procedure success.


  • Scaffold thrombosis [ Time Frame: 30days, 6 months and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]

    Scaffold thrombosis will be categorized as acute (≤1day), subacute (>1day ≤30 days) and late (>30 days).

    Clinical presentation of acute coronary syndrome with angiographic evidence of scaffold thrombosis (angiographic appearance of thrombus within or adjacent to a previously treated target lesion).

    In the absence of angiography, any unexplained death, or acute MI (ST segment elevation or new Q-wave)* in the distribution of the targetlesion within 30 days.


  • Angiographic Endpoint [ Time Frame: 6 months, 2 and 5 years ] [ Designated as safety issue: No ]
    In-segment In-scaffold, proximal and distal Late lumen loss (mm); In-segment In-scaffold, proximal and distal Minimal lumen diameter(mm); In-segment In-scaffold, proximal and distal Diameter stenosis (%) Angiographic Binary Restenosis (%).

  • OCT Endpoint [ Time Frame: 6 months, 2 and 5 years ] [ Designated as safety issue: No ]
    proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.

  • IVUS Endpoint [ Time Frame: 6 months, 2 and 5 years ] [ Designated as safety issue: No ]
    mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area

  • MSCT Endpoint [ Time Frame: 1 and 3 years ] [ Designated as safety issue: No ]
    mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area


Estimated Enrollment: 30
Study Start Date: July 2014
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeoVas BCS
The NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Device: NeoVas BCS
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.
Other Name: NeoVas bioresorbable coronary scaffold

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  • 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, coumadin)
  • Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel
  • Platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02195414

Contacts
Contact: Ting Zhang +86-010-80120666 ting_zhang@lepumedical.com
Contact: Yao-Jun Zhang +86-13770668667 yaojunzhang99@gmail.com

Locations
China, Liaoning
The General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China, 110015
Contact: Ya-Ling Han, PhD    (86)024-28856123    hanyaling@263.com   
Principal Investigator: Ya-Ling Han, PhD         
China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Guo-Sheng Fu, PhD    (86)0751-88206248    fugs@medmail.com.cn   
Sub-Investigator: Guo-Sheng Fu, PhD         
Sponsors and Collaborators
Lepu Medical Technology (Beijing) Co.,Ltd
Investigators
Study Chair: Yaling Han, MD The general hospital of Shenyang military region
Principal Investigator: Guosheng Fu Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
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
  More Information

No publications provided

Responsible Party: Lepu Medical Technology (Beijing) Co.,Ltd
ClinicalTrials.gov Identifier: NCT02195414     History of Changes
Other Study ID Numbers: LPM-201401
Study First Received: July 16, 2014
Last Updated: July 17, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Lepu Medical Technology (Beijing) Co.,Ltd:
NeoVas
Bioresorbable scaffold
Sirolimus
First-in-Man

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014