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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03443999
• Other study ID #: SFLX/Netherlands/001
• Status: Recruiting
• Start date: February 27, 2018
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Sahajanand Medical Technologies Limited
• Contact: Vibhor Bhatia
• Phone: +919049528863
• Email: vibhor.bhatia[@]sahmed.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Supraflex Family Sirolimus-eluting Coronary Stent System
Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care

Locations

Country	Name	City	State
Netherlands	Tergooi Ziekenhuis	Blaricum	North Holland
Netherlands	Amphia Ziekenhuis	Breda	North Brabant
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	South Holland
Netherlands	Catharina Ziekenhuis	Eindhoven	North Brabant
Netherlands	Medical Center Leeuwarden	Leeuwarden	Friesland
Netherlands	Maasstad Ziekenhuis	Rotterdam	South Holland
Netherlands	ZorgSaam Hospital	Terneuzen	Zeeuws- Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Limited

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Target Vessel Failure (TVF)	TVF defined as a composite endpoint of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR)	12 months
Secondary	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	12 months
Secondary	Stent Thrombosis	Stent thrombosis rates according to ARC classification	12 months
Secondary	All Deaths	Cardiac death and non-cardiac death (vascular and non-cardiovascular)	12 months
Secondary	Any Myocardial Infarction (MI)	Q wave and non-Q wave MI	12 months
Secondary	Any Repeat Revascularization	Target lesion revascularization (TLR) and target vessel revascularization (TVR)	12 months