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

S

Sahajanand Medical Technologies

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: Supraflex Family Sirolimus-eluting Coronary Stent System

Study type

Observational

Funder types

Industry

Identifiers

NCT03443999
SFLX/Netherlands/001

Details and patient eligibility

About

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.

Full 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.

Enrollment

7,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

7

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Central trial contact

Vibhor Bhatia

Data sourced from clinicaltrials.gov

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