AzTrials
AzTrials

Coronary Artery DiseaseNCT02305472

NeoVas Bioresorbable Coronary Scaffold Registry Study

A study testing NeoVas BCS in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 27 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial 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. 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
825 participants
Where
27 sitesChina
Study dates
Nov 2014to Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

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 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 ≥1.
  • 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.

Who cannot join

  • 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 ).
Show all 20Show fewer
  • 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.
  • 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.
  • 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, warfarin).
  • Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin, clopidogrel, ticagrelor or prasugrel.
  • Platelet count<100,000 cells/mm3 or>700,000 cells/mm3, a WBC of<3,000 cells/mm3, or documented or suspected liver disease.
  • Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • General Hospital of Armed Police Forces

    Beijing, Beijing Municipality, 100039

  • Aerospace Center Hospital

    Beijing, Beijing Municipality, 100049

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Chengdu Military General Hospital

    Chengdu, Sichuan, 610083

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003

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

    Hangzhou, Zhejiang, 310016

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Kunming General Hospital of Chengdu Military Region

    Kunming, Yunnan, 650032

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200001

  • Shanghai Tenth People'S Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200072

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200433

  • The general hospital of Shenyang military region

    Shenyang, Liaoning, 110016

  • Bethune Peace Hospital of PLA

    Shijiazhuang, Hebei, 050081

  • Affiliated Hospital of The Chinese People's Armed Police Forces Logistic College

    Tianjin, Tianjin Municipality, 300162

  • Tianjin first center hospital

    Tianjin, Tianjin Municipality, 300192

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Wuhan General Hospital of Guangzhou Military

    Wuhan, Hubei, 430070

  • Xijing Hospital, the Fourth Military Medical University

    Xi’an, Shanxi, 710032

  • The First Affiliated Hospital of Xi'An Jiaotong University

    Xi’an, Shanxi, 710061

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 Single Arm Registry Study

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.

Read the 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.

Being tested
NeoVas BCS
Keywords
NeoVas, Bioresorbable Coronary Scaffold, Sirolimus, Registry Trial
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

    Subjects receiving NeoVas BCS

Study groups in NCT02305472
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

    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: 1 year

Secondary outcomes (9)

  1. Device Success

    Successful delivery and deployment of the assigned scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). The success or failure of the first-aid stent is not included.

    Measured: intraoperative

  2. Procedural Success

    Achievement of final in-scaffold residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned scaffold at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR. For the circumstance of two target lesions, both lesions must meet the success criteria.

    Measured: At time of procedure up to 7 days in hospital

  3. 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: 30days, 3,6,9 months and 2,3,4,5 years

  4. Patient oriented composite endpoint

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

    Measured: 30days, 3,6,9 months and 1,2,3,4,5 years

  5. Ischemia-driven Target Lesion Revascularization (iTLR)

    Measured: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years

  6. Ischemia-driven Target Vessel Revascularization (iTVR)

    Measured: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years

  7. All coronary revascularization (PCI and CABG)

    Measured: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years

  8. 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 target lesion within 30 days.

    Measured: 30 days, 3,6,9 months and 1, 2, 3, 4, 5 years

  9. Percentage of patients who experienced angina

    Angina is defined as any angina or angina equivalent symptoms determined by the physician and/or research coordinator after interview of the patient, and as adjudicated by a clinical events committee (CEC).

    Measured: 30days, 3,6,9 months and 1, 2, 3, 4, 5 years

Timeline

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

  1. First posted2 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2020 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
825 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305472
Sponsor's protocol ID
LPM-201403
Status last verified
Dec 2015
First submitted
27 Nov 2014
Last updated
9 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing NeoVas BCS in people with Coronary Artery Disease, run by Lepu Medical Technology (Beijing) Co., Ltd. at 27 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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.

Are results available for this study?

Results are not available in the source record.

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 (time frame: 1 year). 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 NCT02305472.

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 9 Mar 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in