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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT03443999
• Lead Sponsor: Sahajanand Medical Technologies Limited

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 implantation.

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 paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.

The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.

Study Timeline

• Study First Submitted: 2018-02-16
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-23
• Study Start: 2018-02-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE)	12 months	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
Stent Thrombosis	12 months	Stent thrombosis rates according to ARC classification
Any Myocardial Infarction (MI)	12 months	Q wave and non-Q wave MI
Any Repeat Revascularization	12 months	Target lesion revascularization (TLR) and target vessel revascularization (TVR)
Target Vessel Failure (TVF)	12 months	TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)
All Deaths	12 months	Cardiac death and non-cardiac death (vascular and non-cardiovascular)

Trial Locations

Locations (7)

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Friesland, Netherlands

ZorgSaam Hospital; 🇳🇱 Terneuzen, Zeeuws- Vlaanderen, Netherlands

Tergooi Ziekenhuis; 🇳🇱 Blaricum, North Holland, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, South Holland, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, North Brabant, Netherlands

Catharina Ziekenhuis; 🇳🇱 Eindhoven, North Brabant, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, South Holland, Netherlands