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

Last updated: April 22, 2026
Sponsor: Sahajanand Medical Technologies Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Coronary Artery Disease

Heart Disease

Treatment

Supraflex Family Sirolimus-eluting Coronary Stent System

Clinical Study ID

NCT03443999
SFLX/Netherlands/001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. The patient, or legal representative, has been informed of the nature of theregistry and has consented to participate and authorised the collection and releaseof his/her medical information by signing a Patient Informed Consent Form

  3. Treating physician has electively implanted at least one Supraflex Family stent aspart of the patient's planned clinical care.

  4. The patient is willing and able to cooperate with study procedures and requiredfollow up visits

Exclusion

Exclusion Criteria:

  1. Women with known pregnancy or who are lactating

  2. High probability of non-adherence to the follow-up requirements (due to social,psychological or medical reasons)

  3. Currently participating in another study that has not completed the primary endpointor that clinically interferes with the current registry requirements

  4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy ismaintained throughout the peri-surgical period

Study Design

Total Participants: 10000
Treatment Group(s): 1
Primary Treatment: Supraflex Family Sirolimus-eluting Coronary Stent System
Phase:
Study Start date:
February 27, 2018
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Amphia Ziekenhuis

    Breda, North Brabant 4818 CK Breda
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven, North Brabant 5623 EJ
    Netherlands

    Active - Recruiting

  • Tergooi Ziekenhuis

    Blaricum, North Holland 1261 AN
    Netherlands

    Active - Recruiting

  • Medical Center Leeuwarden

    Leeuwarden, Provincie Friesland 8934 AD
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht, South Holland Post bus 444 3300 AK
    Netherlands

    Active - Recruiting

  • Maasstad Ziekenhuis

    Rotterdam, South Holland 3079 DZ
    Netherlands

    Active - Recruiting

  • ZorgSaam Hospital

    Terneuzen, Zeeuws- Vlaanderen 4535 PA
    Netherlands

    Active - Recruiting

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