Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry aims to assess the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in patients requiring stent implantation for coronary artery disease. It focuses on a new generation of drug-eluting stents that utilize a biodegradable polymer and a cobalt-chromium platform, which enhances flexibility and deliverability while maintaining strength. The study will collect data from a real-world patient population to evaluate the stent's performance in routine clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Amphia Ziekenhuis
  Breda, North Brabant, Netherlands Recruiting
• Catharina Ziekenhuis
  Eindhoven, North Brabant, Netherlands Recruiting
• Tergooi Ziekenhuis
  Blaricum, North Holland, Netherlands Recruiting
• Medical Center Leeuwarden
  Leeuwarden, Provincie Friesland, Netherlands Recruiting
• Albert Schweitzer Ziekenhuis
  Dordrecht, South Holland, Netherlands Recruiting
• Maasstad Ziekenhuis
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Dr. A.J.J. IJsselmuiden, MD. — Amphia Hospital, Breda, The Netherlands
• Study coordinator: Vibhor Bhatia
• Email: vibhor.bhatia@sahmed.com
• Phone: +919049528863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.