Post-market follow-up for the SUPRAFLEX CRUZ stent in patients with coronary artery disease
SUPRAFLEX CRUZPost-Market Clinical Follow-up Study
This study is testing how well the SUPRAFLEX CRUZ stent works and if it's safe for people with coronary artery disease who are getting treated in real-life hospital settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 508 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC Academic / other |
| Locations | 21 sites (Elche, Alicante and 20 other locations) |
| Trial ID | NCT05617599 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with multivessel coronary artery disease who are treated with the SUPRAFLEX CRUZ stent.
Not a fit: Patients who may not benefit from this study include those with contraindications for antiplatelet treatment or a life expectancy of less than 12 months.
Why it matters
Potential benefit: If successful, this study could provide valuable evidence supporting the safety and effectiveness of the SUPRAFLEX CRUZ stent, potentially improving treatment options for patients with coronary artery disease.
How similar studies have performed: Other studies evaluating the safety and performance of similar stents have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Elche, Alicante and 20 other locations
- 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)
- Hospital Universitario San Pedro de Alcántara — Cáceres, Spain (Recruiting)
- Hospital General Universitario de Ciudad Real — Ciudad Real, Spain (Recruiting)
- Hospital Universitari Dr. Josep Trueta — Girona, Spain (Recruiting)
- Hospital Universitario Clínico San Cecilio — Granada, Spain (Recruiting)
- Hospital Universitario de Leon — León, Spain (Recruiting)
- Hospital Universitari Arnau de Vilanova — Lleida, Spain (Recruiting)
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- Hospital Parc Tauli — Sabadell, Spain (Recruiting)
- Hospital Clinico Universitario de Salamanca — Salamanca, Spain (Recruiting)
- Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela, Spain (Recruiting)
- Hospital Universitario Virgen Del Rocio — Seville, Spain (Recruiting)
- Hospital Universitario de Toledo — Toledo, Spain (Recruiting)
- Hospital Universitario Y Politécnico La Fé — Valencia, Spain (Recruiting)
- Hospital Universitario Lozano Blesa — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Bruno Garcia, MD, PhD
- Email: brunogb51@gmail.com
- Phone: 0034932746155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.