Status:
RECRUITING
S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System
Lead Sponsor:
Sahajanand Medical Technologies Limited
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief 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 impla...
Detailed 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 paclita...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT03443999
Start Date
February 27 2018
End Date
December 1 2025
Last Update
June 26 2025
Active Locations (7)
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1
Amphia Ziekenhuis
Breda, North Brabant, Netherlands, 4818 CK Breda
2
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands, 5623 EJ
3
Tergooi Ziekenhuis
Blaricum, North Holland, Netherlands, 1261 AN
4
Medical Center Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands, 8934 AD