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

NCT02929030 | Unknown DMC

• 1 other identifier: NANOxijing001
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• target lesion failure (TLF)

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

  12 months

Secondary Outcomes (9)

• Target lesion failure

  1、6、12、24、36、48、60 months

• Patient oriented composite endpoint

  1、6、12、24、36、48、60 months

• all cause death

  1、6、12、24、36、48、60 months

• cardiac death

  1、6、12、24、36、48、60 months

• Myocardial infarction

  1、6、12、24、36、48、60 months

Study Arms (1)

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

Nano DEVICE

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

NANO Plus SES

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with coronary artery disease

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Nanjing First Hospital, Nanjing Medical University: collaborator

Study Sites (1)

Xijing Hospital

Xi’an, Shanxi, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 27497357 BACKGROUND

• 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.

  PMID: 24890170 BACKGROUND

• 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.

  PMID: 41174582 DERIVED

• 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.

  PMID: 34772347 DERIVED

• 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.

  PMID: 31961057 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Lin Tao, PhD

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

• Yao-Jun Zhang, PhD

  Nanjing First Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Yue Li, PhD

  The First Clinical Hospital affiliated to Harbin Medical University

  PRINCIPAL INVESTIGATOR

• Zhiqi Sun, PhD

  Daqing oilfield central hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Wang, PhD

CONTACT

15802929290

Jin-Zan Cai, MSc

CONTACT

15720800327

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 10, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2022
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

CN (1)