S-FLEX Netherlands Registry
A Prospective Evaluation of the Supraflex Family Sirolimus-Eluting Coronary Stent System in a ‘Real-World’ Patient Population
Objective of the Study:
To evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a ‘real-world’ patient population requiring stent implantation.
Primary Endpoint:
- Target Lesion Failure (TLF) at 12 months follow-up. TLF is defined as a composite endpoint comprising cardiac death, target vessel myocardial infarction (both Q-wave and non–Q-wave), or clinically driven target lesion revascularization (TLR) performed via either percutaneous or surgical methods.
Secondary Endpoint (12 Months):
- Overall stent thrombosis.
- All deaths (cardiac, vascular and non-cardiovascular).
- Any myocardial infarction (Q wave and non-Q wave MI).
- Any repeat revascularization (target lesion and target vessel revascularization).
- Target Vessel Failure (TVF): a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
- Major adverse cardiac events (MACE): a composite endpoint of cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods.
10000 Patients Planned
7,238 enrolled
Multicenter
10 sites in the Netherlands
12 months
Planned Follow-up
Study Details | S-FLEX Netherlands Registry | https://clinicaltrials.gov/study/NCT03443999?term=S-FLEX%20Netherland%20registry&rank=1
Lead Investigator:
Dr. A.J.J Ijsselmuiden