NCT02870985

BIOTRONIK Orsiro Pre-Marketing Registration

BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With de Novo Coronary Artery Lesions-VI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Biotronik (Beijing) Medical Device Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The clinical investigation is a non-inferiority, multicenter, blinding evaluation, randomized, parallel controlled clinical study enrolling up to 440 subjects. All subjects will be randomized 1:1 to receive the BIOTRONIK Orsiro SES or the Abbott Xience Prime™ EES, in order to evaluate the efficacy and safety of the SES drug eluting stent in the treatment of coronary artery disease.

Detailed description

Clinical or call follow up visits will take place at 1, 6, 12, 24, 36, 48 and 60 months post procedure. At 9 months (+ 30 days) all subjects will undergo a standard quantitative coronary angiography (QCA) follow up to assess the in-stent LLL as the main efficacious evaluation. Use the major adverse cardiac event (death, myocardial infarction and stent thrombosis) within one year post procedure as the main safety indicators to evaluate the investigational product's safety. The clinical and angiographic data sorting, calculation and statistical analysis will be conducted by an independent data management center and angiographic core laboratory.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coronary Stent

Timeline

• Start date: 2015-07-14
• Primary completion: 2017-04-06
• Completion: 2021-12-01
• First posted: 2016-08-18
• Last updated: 2024-03-04
• Results posted: 2024-03-04

Locations

1 site across 1 country: China