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Recruiting NCT03443999

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

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Supraflex Family Sirolimus-eluting Coronary Stent System.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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

Primary outcome measures

  • Target Lesion Failure (TLF) [Time frame: 12 months]
Secondary outcome measures (6)
  • Target Vessel Failure (TVF) [Time frame: 12 months]
  • Major Adverse Cardiac Events (MACE) [Time frame: 12 months]
  • Stent Thrombosis [Time frame: 12 months]
  • All Deaths [Time frame: 12 months]
  • Any Myocardial Infarction (MI) [Time frame: 12 months]
  • Any Repeat Revascularization [Time frame: 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Netherlands · 7 centers
  • Amphia Ziekenhuis — Breda
  • Catharina Ziekenhuis — Eindhoven
  • Tergooi Ziekenhuis — Blaricum
  • Medical Center Leeuwarden — Leeuwarden
  • Albert Schweitzer Ziekenhuis — Dordrecht
  • Maasstad Ziekenhuis — Rotterdam
  • ZorgSaam Hospital — Terneuzen

Identifiers

NCT: NCT03443999 · SFLX/Netherlands/001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗