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

RECRUITINGSponsored by Sahajanand Medical Technologies Limited
Actively Recruiting
SponsorSahajanand Medical Technologies Limited
Started2018-02-27
Est. completion2025-06
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Coronary Artery DiseaseHeart Disease

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