Clinical Performance of Nano Plus Sirolimus-Eluting Stents in Patients With Coronary Artery Disease
NCT ID: NCT02929030
Last Updated: 2016-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2500 participants
OBSERVATIONAL
2016-08-31
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Nano
The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon
Interventions
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Nano
The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Nanjing First Hospital, Nanjing Medical University
OTHER
Xijing Hospital
OTHER
Responsible Party
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Tao Ling
Professor
Principal Investigators
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Lin Tao, PhD
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital
Yao-Jun Zhang, PhD
Role: PRINCIPAL_INVESTIGATOR
Nanjing First Hospital, Nanjing Medical University
Yue Li, PhD
Role: PRINCIPAL_INVESTIGATOR
The First Clinical Hospital affiliated to Harbin Medical University
Zhiqi Sun, PhD
Role: PRINCIPAL_INVESTIGATOR
Daqing oilfield central hospital
Locations
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Xijing Hospital
Xi’an, Shanxi, China
Countries
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Central Contacts
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Chen Wang, PhD
Role: CONTACT
Phone: 15802929290
Jin-Zan Cai, MSc
Role: CONTACT
Phone: 15720800327
Facility Contacts
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Chen Wang
Role: primary
References
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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.
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.
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.
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.
Other Identifiers
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NANOxijing001
Identifier Type: -
Identifier Source: org_study_id