Health Trials

About this trial

Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).

Eligibility criteria

Qualifiers

≥ 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

Disqualifiers

Not meet inclusion criteria

Contraindication for antiplatelet treatment

Patient life expectancy less than 12 months

Trial design

Treatments tested in this trial

  • SUPRAFLEX CRUZ

Treatment groups

508 Participants
are divided into 1 treatment group

Locations

21
Hospital General Universitario de Elche03203, ElcheAlicante, Spain
Hospital Universitario A Coruña15006, A Coruña Spain
Hospital Universitario de Cruces48903, Barakaldo Spain
Hospital de La Santa Creu I Sant Pau08041, Barcelona Spain

Sponsors and collaborators

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov