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CompletedNCT02542007RECOVERYUpdated Sep 9, 2021

Safety and Efficacy of the Combo Bio-engineered Sirolimus-eluting Stent Versus the Nano Polymer-free Sirolimus-eluting Stent in the Treatment of Patients With de Novo Stenotic Lesions

An interventional study of OrbusNeich Combo stent™ and sirolimus-eluting stent system in Coronary Arteriosclerosis, sponsored by OrbusNeich. Completed at 15 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-09-09.

Sponsored by OrbusNeich · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
440
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To evaluate the safety, efficacy and deliverability of the Combo bio-engineered sirolimus-eluting stent versus the Nano polymer-free sirolimus- eluting stents in the treatment of patients with de novo stenotic lesions of native coronary artery.

Read the detailed description

This is a prospective, multi-center, open-label, non-inferiority, randomized controlled trial which plans to enroll 436 subjects. All subjects enrolled will be randomly assigned to the test group (n=218) and the control group (n=218). Subjects in the test group and the control group will receive Combo stents and Nano stents respectively.

02

Conditions studied

  • Coronary Arteriosclerosis

Keywords

  • intracoronary stent
  • drug eluting stent
  • sirolimus
  • endothelial progenitor cells
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's enrollment of 440 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

OrbusNeich is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with clinical evidence of asymptomatic or symptomatic ischemic heart disease, stable or unstable angina, old myocardial infarction;
  • De novo lesions of native coronary arteries (lesions number ≤2);
  • Target lesion located in one or two different vessels. The number of target lesions in one vessel shall be no more than one;
  • Target vessel diameter between 2.5 and 4.0 mm by visual estimation. Target lesion length ≤ 32mm by visual estimation, which can be covered by one Combo stent with length 38mm or one Nano stent with length 36mm. It is suggested that the selected stent size should cover at least 2 mm (by visual estimation) of normal tissue on each side of the lesion;
  • Target lesion diameter stenosis ≥ 70% by visual estimation;
  • Each target lesion is permitted to implant only one stent at most, except bailout stent;
  • Patients is eligible for PCI and is an acceptable candidate for CABG;
  • Patients with (LVEF) ≥40%;
  • Patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written ;

Exclusion criteria

Exclusion Criteria:

  • Patients with acute myocardial infarction (AMI) within one week;
  • Chronic total occlusion lesion (TIMI 0 flow), Left main disease, Ostial lesion, and/or triple-vessel lesion that might require treatment, bifurcation lesions with a side branch diameter >2.5mm or graft lesions;
  • Heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment;
  • In-stent restenosis;
  • Thrombotic lesion;
  • Patients who had received any other stent in the past six months;
  • Patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl);
  • Patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months;
  • Patients who are allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, stainless steel , polymer, or with to aspirin or clopidogrel or ticagrelor;
  • Patients who had previously received murine therapeutic antibodies and exhibited sensitization through the production of HAMA;
  • Patients with a less than 1year;
  • Patients who had participated in another drug or device trial that has not completed the primary endpoint;
  • Patient who has received any organ transplant or is on a waiting list for any organ transplant;
  • Patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
440 participants (actual)

Study arms

  • Experimental
    OrbusNeich Combo stent™

    The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

    Device: OrbusNeich Combo stent™

  • Active comparator
    Nano Polymer-free sirolimus-eluting stent system

    The Nano polymer-free sirolimus-eluting stent produced by LePu medical.

    Device: sirolimus-eluting stent system

Interventions

  • DeviceOrbusNeich Combo stent™

    The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

  • Devicesirolimus-eluting stent system

    Also known as: Nano Polymer-free sirolimus-eluting stent system

06

What researchers measure

Primary outcomes

  1. In-segment late lumen loss (LLL)

    In-segment late lumen loss (LLL) refers to within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.

    Time frame: 9 months post-procedure

Secondary outcomes

  1. Device-oriented target lesion failure (TLF)

    The device-oriented target lesion failure (TLF) defined as a composite of cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (i-TLR)

    Time frame: 30 days, 6 months, 12 months and annually up to 5 years

  2. Patient-oriented composite endpoint

    The patient-oriented composite endpoint includes all-cause death, all MIs, or any revascularization

    Time frame: 30 days, 6 months, 12 months and annually up to 5 years

  3. In-stent late lumen loss (LLL)

    Time frame: 9 months post-procedure

  4. In-stent and In-segment binary restenosis (BR)

    Time frame: 9 months post-procedure

  5. In-stent and In-segment minimal lumen diameter (MLD)

    Time frame: 9 months post-procedure

  6. Definite and probable stent thrombosis (ST)

    Definite and probable stent thrombosis (ST) in acute, sub-acute, late and very late period per Academic Research Consortium (ARC) definition criteria

    Time frame: acute (0-24 hours), sub-acute (24 Hours to 30 Days), late (30 Days to 1 year) and very late (1 year to 5 years) period per Academic Research Consortium (ARC) definition criteria

07

Study locations

15 sites
  • Daqing General Oilfield Hospital
    Daqing, Heilongjiang, China
  • Jiangsu Province Hospital
    Nanjing, Jiangsu, China
  • Nanjing First Hospital
    Nanjing, Jiangsu, China
  • China Japan Union Hospital of Jilin University
    Changchun, Jilin, China
  • The people Hospital of Liaoning Province
    Shenyang, Liaoning, China
  • The Secondary Affiliated Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan, China
  • Kunming General Hospital of Chengdu Military region
    Kunming, Yunnan, China
  • Beijing Chao Yang Hospital
    Beijing, China
  • The Military General Hospital of Beijing PLA
    Beijing, China
  • Bethune International Peace Hospital
    Shijiazhuang, China
  • Tianjing Chest Hospital
    Tianjing, China
  • TEDA International Cardiovascular Hospital
    Tianjin, China
  • Tianjin Medical University General Hospital
    Tianjin, China
  • The First Affiliated Hospital of the Fourth Military Medical University
    Xi'an, Shanxi, China
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2015, a primary completion of May 2017 and a completion of Jun 2021. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2015
First posted
Sep 4, 2015
Start
May 2015
Primary completionActual
May 27, 2017
CompletionActual
Jun 10, 2021
Last update
Sep 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02542007
Lead sponsor
OrbusNeich
Collaborators
CCRF Inc., Beijing, China, OrbusNeich Medical (Shenzhen), Co. Ltd.
Responsible party
Sponsor
First posted
Sep 4, 2015
Start date
May 2015
Primary completion
May 27, 2017
Completion
Jun 10, 2021
Last update
Sep 9, 2021

Study contacts

Tao Ling, M.D.
principal investigator · The First Affiliated Hospital of the Fourth Medical University
Xu Bo, M.D
principal investigator · The Secondary Affiliated Hospital of Harbin University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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