Prsentation PowerPoint

1
P I S C E S
Paclitaxel In-Stent Controlled Elution
Study Principal Investigator Professor P. W.
Serruys Thoraxcenter, Erasmus University Medical
Center
2
Objective

• To determine the optimal dose and kinetic release
  pattern for paclitaxel

3
Study Endpoints

• MACE at 4 months,
• Angiographic late loss within the stent
• Rate of binary restenosis
• Vessel diameter stenosis QCA at 4 months
• Neointimal tissue vol. IVUS at 4 months

4
Trial design and methods

• Non-randomised, sequentially-enrolled, six-arm,
  dose-ranging registry
• Single de novo lesions in native coronary
  arteries
• 191 patients, 10 sites in 7 countries
• 6 different formulation groups
• - drug dose 10 or 30µg
• - elution release kinetics first order, zero
  order
• - direction of elution mural, biridectional
• - estimated duration of elution 5, 10, 30
  days

5
Study Device

• MEDSTENT Stainless steel drug eluting stent
  (Paclitaxel)
• Conor Medsystems

6
Release formulations
7
QCA in-stent analysis at four months
8
QCA In-stent analysis at four months
9
IVUS In-stent analysis at four months
10
IVUS In-stent analysis at four months
11
Conclusions
Other studies are warranted to confirm these
promising results