TCD-10023PK Trial
2
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20 patients, single arm, pharmocokinetics. Published.
Featured products: Ultimaster™ Tansei™ Sirolimus Eluting Coronary Stent System, Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System
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Objectives
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Study design
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Other findings
Objectives
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- Assess the pharmacokinetics of sirolimus after Ultimaster implantation
- Evaluate the systemic concentration and potential toxicity of sirolimus
- Assess endothelial function
- Investigate the safety and tolerability profile of Ultimaster, along with therapeutic outcomes
Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105.
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Study design
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PK, pharmacokinetics.
Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105; Data on file at Terumo Europe
Other findings
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6 months:
- Endothelial function well preserved
- In-stent late loss: 0.10±0.28 mm
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Up to 12 months:
- No signs of sirolimus toxicity or other safety concerns
Stojkovic S et al. Fundam Clin Pharmacol 2014;29:95–105.
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Featured products
3
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Ultimaster™ Tansei™
Sirolimus Eluting Coronary Stent System
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Ultimaster Nagomi™
Sirolimus Eluting Coronary Stent System