About this trial
The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
The patient is willing and able to cooperate with study procedures and required follow up visits
Disqualifiers
Women with known pregnancy or who are lactating
High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period
Trial population
Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex Family sirolimus-eluting stent.
Trial design
Other
Prospective
Treatments tested in this trial
Supraflex Family Sirolimus-eluting Coronary Stent System
DevicePatient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care
Treatment groups
Trial outcomes
Primary outcomes
Target Lesion Failure (TLF)
TLF defined as a composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Secondary outcomes
Target Vessel Failure (TVF)
TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)
Major Adverse Cardiac Events (MACE)
MACE defined as 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
Stent Thrombosis
Stent thrombosis rates according to ARC classification
All Deaths
Cardiac death and non-cardiac death (vascular and non-cardiovascular)
Sponsors and contacts
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