Biomatrix; Biomatrix Flex; Nobori
DeviceBiodegradable polymer-coated biolimus-eluting stents
Other names: BP-BES
NCT Number: NCT03507205
The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world.
The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).
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Observational
Wonju Severance Christian Hospital, Wŏnju, Gangwon-do, South Korea
The Grand Drug-Eluting Stent (Grand-DES) Registry incorporated five different multicenter registries in South Korea. The EXCELLENT prospective cohort and the EXCELLENT-PRIME registry were dedicated for durable polymer-coated everolimus-eluting stents (DP-EES; Xience V/Promus and Xience Prime) or 1st-generation sirolimus-eluting stents (Cypher), the HOST-RESOLINTE and RESOLUTE-Korea registry for durable polymer-coated zotarolimus-eluting stents (DP-ZES; Resolute Integrity and Endeavor Resolute) or 1st-generation Endeavor-ZES, and the HOST-BIOLIMUS-3000-Korea registry for biodegradable polymer-coated biolimus-eluting stents (BP-BES; Biomatrix, Biomatrix Flex, and Nobori). During the period of 2008 through 2014, all registries enrolled all-comers without any exclusion criteria except patient's withdrawal of consent.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biodegradable polymer-coated biolimus-eluting stents
Other names: BP-BES
Durable polymer-coated everolimus-eluting stents
Other names: DP-EES-Prime
Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents
Other names: DP-EES; SES
Durable polymer-coated zotarolimus-eluting stents
Other names: Resolute Integrity
Durable polymer-coated zotarolimus-eluting stents
Other names: DP-ZES
Time frame: 36 months
A composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization
Time frame: 36 months
A composite of all-cause death, all-cause myocardial infarction, and any repeat revascularization
Time frame: 36 months
All-cause death
Time frame: 36 months
Cardiac death
Time frame: 36 months
All-cause myocardial infarction
Time frame: 36 months
Target-vessel myocardial infarction
Time frame: 36 months
Any repeat revascularization
Time frame: 36 months
Clinically-driven target vessel revascularization
Time frame: 36 months
Clinically-driven target lesion revascularization
Time frame: 36 months
Definite or probable stent thrombosis
Seoul National University Hospital
Other
Acronym: Grand-DES
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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