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Coronary Artery DiseasePhase 1NCT02195414

NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

A Phase 1 study testing NeoVas BCS in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
NeoVas BCS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
2 sitesChina
Study dates
Jul 2014to Sep 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 )
Show all 20Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

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

    Hangzhou, Zhejiang, 310016

  • The General Hospital of Shenyang Military Region

    Shenyang, Liaoning, 110015

Other trials in China

About this study

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

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.

Read the 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.

Being tested
NeoVas BCS
Keywords
NeoVas, Bioresorbable scaffold, Sirolimus, First-in-Man
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NeoVas BCSDevice

    Also called NeoVas bioresorbable coronary scaffold

    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.

Study groups in NCT02195414
Study groupRoleWhat they receive
NeoVas BCSExperimentalThe NeoVas sirolimus-eluting bioresorbable coronary scaffold system is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
Receives: Device: NeoVas BCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (32)

  1. Target Lesion Failure

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

    Measured: 6 months

  2. Target Lesion Failure

    Measured: 1 year

  3. Target Lesion Failure

    Measured: 2 years

  4. Target Lesion Failure

    Measured: 3 years

  5. Target Lesion Failure

    Measured: 4 years

  6. Target Lesion Failure

    Measured: 5 years

  7. Patient Oriented Composite Endpoint

    Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.

    Measured: 30 days

  8. Patient Oriented Composite Endpoint

    Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization.

    Measured: 6 months

  9. Patient Oriented Composite Endpoint

    Measured: 1 year

  10. Patient Oriented Composite Endpoint

    Measured: 2 years

  11. Patient Oriented Composite Endpoint

    Measured: 3 years

  12. Patient Oriented Composite Endpoint

    Measured: 4 years

  13. Patient Oriented Composite Endpoint

    Measured: 5 years

  14. Acute Success (Clinical Device and Clinical Procedure)

    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.

    Measured: acute

  15. Scaffold Thrombosis

    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.

    Measured: 30days

  16. Scaffold Thrombosis

    Measured: 6 months

  17. Scaffold Thrombosis

    Measured: 1 year

  18. Scaffold Thrombosis

    Measured: 2 years

  19. Scaffold Thrombosis

    Measured: 3 years

  20. Scaffold Thrombosis

    Measured: 4 years

  21. Scaffold Thrombosis

    Measured: 5 years

  22. Angiographic Endpoint

    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 (%).

    Measured: 6 months

  23. Angiographic Endpoint

    Measured: 2 years

  24. Angiographic Endpoint

    Measured: 5 years

  25. OCT Endpoint

    proportion of covered struts, malapposed struts; neointimal hyperplasia (NIH) area, volume; NIH volume obstruction.

    Measured: 6 months

  26. OCT Endpoint

    Measured: 2 years

  27. OCT Endpoint

    Measured: 5 years

  28. IVUS Endpoint

    mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area

    Measured: 6 months

  29. IVUS Endpoint

    Measured: 2 years

  30. IVUS Endpoint

    Measured: 5 years

  31. MSCT Endpoint

    mean/minimal vessel area, mean/minimal lumen area, mean/minimal stent area

    Measured: 1 year

  32. MSCT Endpoint

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionNov 2014
  4. Study completionSep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195414
Sponsor's protocol ID
LPM-201401
Status last verified
Mar 2016
First submitted
16 Jul 2014
Last updated
11 Apr 2016
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NeoVas BCS in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure(TLF) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195414.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.

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