Post-market follow-up for the SUPRAFLEX CRUZ stent in patients with coronary artery disease

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 multicenter, prospective, non-randomized study aims to evaluate the clinical safety and performance of the SUPRAFLEX CRUZ stent in a real-world population with multivessel coronary artery disease. The study will include all consecutive patients treated with the stent according to routine hospital practices, ensuring a comprehensive assessment of its effectiveness under daily clinical conditions. By adhering to EU Medical Device regulations, the study seeks to confirm the stent's compliance and safety in a diverse patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 years old and;
* Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use
* Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries.
* Substudy: Patients with Ejection Fraction \<45% by Echocardiography
* Informed consent signed

Exclusion Criteria:

* Not meet inclusion criteria
* Contraindication for antiplatelet treatment
* Patient life expectancy less than 12 months

Where it's running

• Hospital General Universitario de Elche
  Elche, Alicante, Spain Recruiting
• Hospital Universitario A Coruña
  A Coruña, Spain Recruiting
• Hospital Universitario de Cruces
  Barakaldo, Spain Recruiting
• Hospital Universitari Vall D'Hebron
  Barcelona, Spain Recruiting
• Hospital de La Santa Creu I Sant Pau
  Barcelona, Spain Recruiting
• Hospital General Universitario de Castellón
  Castelló, Spain Recruiting

Study contacts

• Study coordinator: Bruno Garcia, MD, PhD
• Email: brunogb51@gmail.com
• Phone: 0034932746155

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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.