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Status unknownNCT02929030Updated Dec 30, 2016

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

An observational study in Coronary Artery Disease, sponsored by Xijing Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-12-30.

Sponsored by Xijing Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Xijing Hospital is the lead sponsor of 465 studies on the registry; 157 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with coronary artery disease

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • NANO Plus SES

    All 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.

    Device: Nano

Interventions

  • DeviceNano

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

06

What researchers measure

Primary outcomes

  1. target lesion failure (TLF)

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

    Time frame: 12 months

Secondary outcomes

  1. Target lesion failure

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

    Time frame: 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

    Time frame: 1、6、12、24、36、48、60 months

  3. all cause death

    Time frame: 1、6、12、24、36、48、60 months

  4. cardiac death

    Time frame: 1、6、12、24、36、48、60 months

  5. Myocardial infarction

    Time frame: 1、6、12、24、36、48、60 months

  6. Stent thrombosis

    Time frame: 1、6、12、24、36、48、60 months

  7. Target lesion revascularization

    Time frame: 1、6、12、24、36、48、60 months

  8. Target vessel revascularization

    Time frame: 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

    Time frame: 1、6、24、36、48、60 months

07

Study locations

1 of 1 sites recruiting
  • Xijing Hospital
    Xi'an, Shanxi, China
    • Chen Wang · Contact · 15802929290
    Recruiting
08

References and documents

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 ↗
  • 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02929030
Lead sponsor
Xijing Hospital
Collaborators
Nanjing First Hospital, Nanjing Medical University
Responsible party
Tao Ling (Professor, Xijing Hospital) — Principal investigator
First posted
Oct 10, 2016
Start date
Aug 2016
Primary completion
Jan 2018 (estimated)
Completion
Jan 2022 (estimated)
Last update
Dec 30, 2016

Study contacts

Chen Wang, PhD
Contact
15802929290
Jin-Zan Cai, MSc
Contact
15720800327
Lin Tao, PhD
principal investigator · Xijing Hospital
Yao-Jun Zhang, PhD
principal investigator · Nanjing First Hospital, Nanjing Medical University
Yue Li, PhD
principal investigator · The First Clinical Hospital affiliated to Harbin Medical University
Zhiqi Sun, PhD
principal investigator · Daqing oilfield central hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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