bifurcations lesion coronary artery sclerosis
Conditions
Interventions
Comparison of three groups :
Group A : normal bare metal stent with normal balloons
Group B: normal bare metal stent with paclitaxel balloons
Group C: paclitaxel eluting stent with normal balloons
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - stable angina pectoris or unstable angina and documented ischemia or silent ischemia. - the target lesion has a major native coronary artery (>2.5 mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2 mm). - de novo lesion
Exclusion criteria
Exclusion criteria: - in stent restenosis of target lesion - severe calcifications with an undilatable lesion during balloon predilatation (PTRA could be considered) - untreated significant lesion greater than 50% diameter stenosis remaining proximal of distal to the target intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic evaluation of reduction of vessel diameter at 6 months follow-up at the treated segments ( incidence of late Lumen Loss ) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Target vessel failure* at 6 months follow up. The incidence of Major Adverse Coronary or Cerebral events ( MACCE ) at 6 month follow up. | — |
Countries
Netherlands
Outcome results
None listed