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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahajanand Medical Technologies Limited

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex Family sirolimus-eluting stent.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Supraflex Family Sirolimus-eluting Coronary Stent System

    Device

    Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Target Lesion Failure (TLF)

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.

Time frame
12 months

Secondary outcomes

1

Target Vessel Failure (TVF)

TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)

Time frame
12 months
2

Major Adverse Cardiac Events (MACE)

MACE defined as a composite endpoint of cardiac death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical methods

Time frame
12 months
3

Stent Thrombosis

Stent thrombosis rates according to ARC classification

Time frame
12 months
4

All Deaths

Cardiac death and non-cardiac death (vascular and non-cardiovascular)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.