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Coronary Artery DiseaseNCT02929030

Clinical Performance of Nano Plus Sirolimus-Eluting Stents in Patients With Coronary Artery Disease

An observational study of Coronary Artery Disease, run by Xijing Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Nano
Type of treatment
Medical device
How many people
2,500 participants
Where
1 siteChina
Study dates
Aug 2016to Jan 2022
How long will I take part?
5 Years
Phase
Observational
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary artery disease

Who may be able to join

  • 18-85 years old, male or non-pregnancy female;
  • Patients with coronary artery disease who match the indication of stent implantation;
  • Patients who can understand the nature of the study, agree to participate and accept clinical follow-up;

Who cannot join

  • Patients who can not tolerate the material or medication in this study;
  • Pregnancy or lactation women
  • Patients who had participated in another investigational drug or device trial that has not completed the primary endpoint;
  • Patients are, in the opinion of the investigator, unable to comply with the requirements of the study protocol

Trial locations and contacts

1 site in 1 country.

Chen Wang, PhD contact

15802929290

Jin-Zan Cai, MSc contact

15720800327

China1 site, 1 recruiting

  • Xijing Hospital

    Xi’an, Shanxi

    Chen Wang, 15802929290

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Polymer-free Sirolimus-eluting Coronary Stents in Patients With Coronary Artery Disease.

The study aims to evaluate the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . The primary endpoint is target lesion failure, a composite endpoint of cardiac death, target vessel related myocardial infarction and clinically-driven target lesion revascularization at 1 year follow-up.

Read the detailed description

This is a prospective, multicenter, single arm clinical registry investigating the safety and efficacy of polymer-free sirolimus-eluting coronary stent system (NANO plus) in patients with coronary artery disease . In total, we plan to recruit 2500 patients in real world setting. The patients will be followed clinically at 1-, 6- month and 1-, 2-, 3-, 4-, 5-year. All clinical data will be collected and managed by statistical center, clinical endpoint adjudication committee.

Being tested
Nano
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.

  • NanoDevice

    The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon

Study groups in NCT02929030
Study groupRoleWhat they receive
NANO Plus SESAll patients will be treated with NANO plus sirolimus-eluting stent. Patients will be prescribed with clopidogrel and aspirin before the index procedure. The lesions will be predilted if necessary before stent implantation. There are no specific limitations on coronary lesions according the study criteria.
Receives: Device: Nano

What is being measured

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

  1. target lesion failure (TLF)

    cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization

    Measured: 12 months

Secondary outcomes (9)

  1. Target lesion failure

    a composite endpoint of cardiac death, target lesion related myocardial infarction, and/or target lesion revascularization

    Measured: 1、6、12、24、36、48、60 months

  2. Patient oriented composite endpoint

    a composite endpoint of all cause death, all myocardial infarction and all revascularization

    Measured: 1、6、12、24、36、48、60 months

  3. all cause death

    Measured: 1、6、12、24、36、48、60 months

  4. cardiac death

    Measured: 1、6、12、24、36、48、60 months

  5. Myocardial infarction

    Measured: 1、6、12、24、36、48、60 months

  6. Stent thrombosis

    Measured: 1、6、12、24、36、48、60 months

  7. Target lesion revascularization

    Measured: 1、6、12、24、36、48、60 months

  8. Target vessel revascularization

    Measured: 1、6、12、24、36、48、60 months

  9. target lesion failure

    cardiac death, target vessel related myocardial infarction and/or clinically driven target lesion revascularization

    Measured: 1、6、24、36、48、60 months

Timeline

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

  1. First posted10 Oct 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
2,500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02929030
Sponsor's protocol ID
NANOxijing001
Status last verified
Dec 2016
First submitted
6 Oct 2016
Last updated
30 Dec 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Suwannasom P, Onuma Y, Benit E, Gach O, von Birgelen C, Hofma SH, Sotomi Y, Bo X, Zhang YJ, Gao R, Garcia-Garcia HM, Wykrzykowska JJ, de Winter RJ, Serruys PW. Evaluation of vascular healing of polymer-free sirolimus-eluting stents in native coronary artery stenosis: a serial follow-up at three and six months with optical coherence tomography imaging. EuroIntervention. 2016 Aug 5;12(5):e574-83. doi: 10.4244/EIJV12I5A97.

    PubMed 27497357

  • Zhang Y, Chen F, Muramatsu T, Xu B, Li Z, Ge J, He Q, Yang Z, Li S, Wang L, Wang H, He B, Li K, Qi G, Li T, Zeng H, Peng J, Jiang T, Zeng Q, Zhu J, Fu G, Bourantas CV, Serruys PW, Huo Y. Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial. Chin Med J (Engl). 2014;127(11):2153-8.

    PubMed 24890170

  • He X, Liu Y, Yin Z, Li F, van Geuns RJ, Garg S, Onuma Y, Serruys PW, Gao C, Tao L. Mid-term outcomes of paclitaxel-coated balloon for de novo non-small coronary lesions: a pooled analysis. BMC Med. 2025 Oct 31;23(1):598. doi: 10.1186/s12916-025-04429-9.

    PubMed 41174582

  • Dai Y, Wang R, Chen F, Zhang Y, Liu Y, Huang H, Yang P, Zhang R, Zheng B, Gao C, Chen Y, Tao L. Clinical outcomes in 2481 unselected real-world patients treated with a polymer-free sirolimus-eluting stent: 3 years results from the NANO multicenter Registry. BMC Cardiovasc Disord. 2021 Nov 12;21(1):537. doi: 10.1186/s12872-021-02356-0.

    PubMed 34772347

  • Liu Y, Zhang Y, Li Y, Qi T, Pan D, Wang H, Liu C, Ma D, Fang Z, Zhang R, Mou F, Tao L; NANO All-Comers Registry Investigators. One-year clinical results of the NANO registry: A multicenter, prospective all-comers registry study in patients receiving implantation of a polymer-free sirolimus-eluting stent. Catheter Cardiovasc Interv. 2020 Feb;95 Suppl 1:658-664. doi: 10.1002/ccd.28734. Epub 2020 Jan 21.

    PubMed 31961057

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Xijing Hospital at 1 site 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 3 inclusion and 4 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 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Chen Wang, PhD (15802929290), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

target lesion failure (TLF) (time frame: 12 months). 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 NCT02929030, which also lists 5 linked publications.

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 30 Dec 2016.

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