S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System

Study Overview
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Brief Summary
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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.

Detailed Description
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To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform. The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.

Official Title
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Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Supraflex Family Sirolimus-eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Supraflex Family Sirolimus-eluting Coronary Stent System|Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Vessel Failure (TVF) | TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) | 12 months | 
| 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 | 12 months | 
| Stent Thrombosis | Stent thrombosis rates according to ARC classification | 12 months | 
| All Deaths | Cardiac death and non-cardiac death (vascular and non-cardiovascular) | 12 months | 
| Any Myocardial Infarction (MI) | Q wave and non-Q wave MI | 12 months | 
| Any Repeat Revascularization | Target lesion revascularization (TLR) and target vessel revascularization (TVR) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Sirolimus-eluting Stent, Biodegradable Polymers