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

  • STATUS
    Recruiting
  • End date
    Dec 29, 2024
  • participants needed
    5000
  • sponsor
    Sahajanand Medical Technologies Pvt. Ltd.
Updated on 26 February 2022
sirolimus

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 IdentifierNCT03443999
SponsorSahajanand Medical Technologies Pvt. Ltd.
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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