10 results
To establish superiority of the biolimus-eluting (BiomatrixTM) stent compared with an otherwise identical bare-metal stent (GazelleTM) in acute ST-segment elevation myocardial infarction (STEMI) in terms of the composite endpoint of cardiac death,…
The primairy objective of this study is to evaluate the safety and efficacy of the Janus OPTIMA stent in the treatment of the novo lesions in native cotronary arteries with a maximum lenght of 28 mm and a diameter of 2.5 - 4.0 mm
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
ObjectiveTo investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal…
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
To demonstrate non-inferiority in terms of neointimal coverage of Cre8 (CID) Drug Eluting Stent, evaluated at three months afterstent implantation, compared to Vision/Multilink 8 (Abbott) Bare Metal Stent evaluated at one month, in terms of…
To evaluate the safety and efficacy of PRX-102 compared to agalsidase beta in Fabry disease patients with impaired renal function.
* To evaluate the effectiveness of contemporary PCI treatment of de novo 3-vessel disease following the heart team selection applying the SYNTAX Score II with pressure wire functional assessment and IVUS guidance (SYNTAX II strategy).* To establish…
The primary objective is to establish the non-inferiority of the Synergy stent relative to the Xience stent for prevention of MACE. The effect measure is the difference in the rate of MACE in patients randomized to treatment with the Synergy ( index…
In this study we will investigate how quickly and to what extent ganaplacide is absorbed, transported, and eliminated from the body. Ganaplacide will be radioactively labelled with carbon-14 (14C). In this way, ganaplacide can be traced in blood,…