RecruitingNCT03443999

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

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

Sponsor

Sahajanand Medical Technologies Limited

Enrollment

10,000 participants

Start Date

Feb 27, 2018

Study Type

OBSERVATIONAL

Conditions

Coronary Artery Disease

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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

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