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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Supraflex Family Sirolimus-eluting Coronary Stent System

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Vibhor Bhatia; Phone Number: +919049528863; Email: vibhor.bhatia@sahmed.com

Study Locations

• Netherlands
  • North Brabant
    • Breda, North Brabant, Netherlands, 4818 CK Breda
      • Recruiting
      • Amphia Ziekenhuis
    • Eindhoven, North Brabant, Netherlands, 5623 EJ
      • Recruiting
      • Catharina Ziekenhuis
  • North Holland
    • Blaricum, North Holland, Netherlands, 1261 AN
      • Recruiting
      • Tergooi Ziekenhuis
  • Provincie Friesland
    • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
      • Recruiting
      • Medical Center Leeuwarden
  • South Holland
    • Dordrecht, South Holland, Netherlands, Post bus 444 3300 AK
      • Recruiting
      • Albert Schweitzer Ziekenhuis
    • Rotterdam, South Holland, Netherlands, 3079 DZ
      • Recruiting
      • Maasstad Ziekenhuis
  • Zeeuws- Vlaanderen
    • Terneuzen, Zeeuws- Vlaanderen, Netherlands, 4535 PA
      • Recruiting
      • ZorgSaam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Real-world patient population assigned for PCI who present with at least one angiographically documented coronary artery lesion suitable for percutaneous treatment with implantation of Supraflex Family sirolimus-eluting stent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Stent Thrombosis	Stent thrombosis rates according to ARC classification	12 months
All Deaths	Cardiac death and non-cardiac death (vascular and non-cardiovascular)	12 months
Any Myocardial Infarction (MI)	Q wave and non-Q wave MI	12 months
Any Repeat Revascularization	Target lesion revascularization (TLR) and target vessel revascularization (TVR)	12 months

Collaborators and Investigators

• Sponsor: Sahajanand Medical Technologies Limited
• Investigators: Principal Investigator: Dr. A.J.J. IJsselmuiden, MD., Amphia Hospital, Breda, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Sirolimus-eluting Stent; Biodegradable Polymers
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Sirolimus
• Other Study ID Numbers: SFLX/Netherlands/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No