coronary disease stenosis
Conditions
Interventions
Study Group - predilatation
Target lesion preparation in study group should be performed by inflation of
BEO high pressure NC balloon catheter with pressure at least 24 atm. If this
inflation does n
Sponsors
SIS MEDICAL AG
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient must be >18 years of age - Patient is willing to comply with specified follow-up evaluations; - Patient has stable or unstable angina diagnosed - De novo lesion - Vessel diameter between 2.25 and 4.0 mm - Lesion qualified for predilatation or for direct stenting strategy are allowed - Patient has no more than two-vessel disease and no more than one lesion per vessel - Patient with target lesion localized in bifurcations can be enrolled to the study - The subject has been informed of the nature of the study and has been provided and signed written informed consent approved by the appropriate Ethics Committee (EC)
Exclusion criteria
Exclusion criteria: - Visible thrombus in angiography - Total occlusion - More than one lesion in target vessel - Diagnosis of myocardial infarction - Pregnant or nursing patient or planned pregnancy in the period up to 1 year following index procedure - Patient with contraindications for 12 months of dual antiplatelet therapy - Patient with contraindications for DES or BVS implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Stent apposition assessed in OCT post index procedure - Dissection assessed in OCT post index procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| - Procedural success - succesfull balloon delivery and predilatation, finally postdilatation without dissection requiring additional stent implantation - Periprocedural complications assessed in angiography, eg. slowflow, no-flow, distal embolization, angiographic dissection - Periprocedural MI - Death, re-MI in 9M FU - Re-PCI, TLR / TVR / non-TVR in 9M FU | — |
Countries
Netherlands
Outcome results
None listed