S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
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- STATUS
- Recruiting
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- End date
- Dec 29, 2024
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- participants needed
- 5000
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- sponsor
- Sahajanand Medical Technologies Pvt. Ltd.
Summary
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.
Description
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.
Details
| Condition | Coronary Artery Disease |
|---|---|
| Treatment | Supraflex Sirolimus-eluting Coronary Stent System, Supraflex Family Sirolimus-eluting Coronary Stent System |
| Clinical Study Identifier | NCT03443999 |
| Sponsor | Sahajanand Medical Technologies Pvt. Ltd. |
| Last Modified on | 26 February 2022 |
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