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Clinical Trials in the Netherlands / NCT03443999
Recruiting Observational

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

NCT03443999 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Sahajanand Medical Technologies Limited
Phase
Observational
Started
2018-02-27
Last updated
2026-04-23

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Supraflex Family Sirolimus-eluting Coronary Stent System

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. 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 3. Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care. 4. The patient is willing and able to cooperate with study procedures and required follow up visits 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 endpoint or that clinically interferes with the current registry requirements 4. Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period

Primary outcome measure(s)

  • Target Lesion Failure (TLF) — 12 months
    TLF defined as a composite of cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically-driven target lesion revascularization (TLR) by percutaneous or surgical methods.

Trial sites (7)

FacilityCityRegionStatus
Amphia Ziekenhuis Breda North Brabant Recruiting
Catharina Ziekenhuis Eindhoven North Brabant Recruiting
Tergooi Ziekenhuis Blaricum North Holland Recruiting
Medical Center Leeuwarden Leeuwarden Provincie Friesland Recruiting
Albert Schweitzer Ziekenhuis Dordrecht South Holland Recruiting
Maasstad Ziekenhuis Rotterdam South Holland Recruiting
ZorgSaam Hospital Terneuzen Zeeuws- Vlaanderen Recruiting

Other trials for the same condition

The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an All-comers PCI Population With Unrestrictive Use of the HT Supreme Sirolimus-eluting Stent Recruiting
Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation Recruiting
Randomization of Single vs Multiple Arterial Grafts Recruiting
Surgical Versus Percutaneous Revascularization in Patients With Reduced Left Ventricular Function (STICH 3.0-NL) Recruiting
Drug-Eluting Balloon Treatment vs. Guideline-Directed Medical Therapy for the Treatment of Lipid-Rich Plaques Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03443999 on ClinicalTrials.gov ↗ ← All trials in the Netherlands