Coronary artery stenosis coronary atherosclerosis
Conditions
Interventions
None listed
Sponsors
STENTYS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age between 18 years and 80 years. 2. Patients with an indication to receive a STENTYS-SES according to the IFU.* 3. Signed Informed Consent. 4. Reference Vessel Diameter >2.5mm and
Exclusion criteria
Exclusion criteria: Clinical: 1. Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives 2. Currently enrolled in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 3. Patients on anticoagulation therapy (Coumadin). 4. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, sirolimus, contrast material. 5. Known thrombocytopenia (PLT30% by visual assessment 13. Staged procedure is planned within 30 days* 14. Target lesion is a chronic total occlusion 15. Perforated vessels evidenced by extravagation of contrast media;* Treatment of other lesions during the same procedure in target- and non-target vessel is allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success, defined as the ability to cross with the device and deploy the stent as intended at the target lesion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Geographical miss, defined as the entire length of the stenotic segment not fully covered by the total length of the stent. 2. Angiographic success, defined as final result | — |
Countries
Netherlands
Outcome results
None listed