BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With de Novo Coronary Artery Lesions-VI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Biotronik (Beijing) Medical Device Ltd.
- Enrollment
- 440
- Locations
- 1
- Primary Endpoint
- In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
In-stent Late Lumen Loss at 9 Months as Assessed by the Core Laboratory QCA Analysis
Time Frame: At 9 months post procedure
QCA data will be provided by an independent core laboratory. A separate report with descriptive statistics will be provided by the core laboratory in accordance with their guidelines. For the primary endpoint, both the lesion and patient level analysis will be done for 9-month in-stent LLL. The analysis on patient level for FAS is considered as main analysis. Other analysis based on lesion level and/or PPS is only for supportive purposes.
Secondary Outcomes
- Number of Participants With All-cause Death(At 5 years post-procedure)
- Number of Participants With Main Adverse Cardiac Event (MACE)(At 5 years post-procedure)
- Number of Participants With TLR(At 5 years post-procedure)
- Number of Participants With Myocardial Infarction(At 5 years post-procedure)
- Number of Participants With TVR Myocardial Infarction(At 5 years post-procedure)
- Number of Participants With Cardiac Death(At 5 years post-procedure)
- In-stent Thrombus(At 5 years post-procedure)