12 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
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…
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…
Primary objective of this trial is to investigate in a double blind randomized controlled trial in children undergoing open heart surgery if NO exposure during CPB reduces the postoperative duration of invasive mechanical ventilation (defined as…
* 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…
To assess efficacy and safety of ivosidenib/enasidenib vs. placebo in combination with induction therapy and consolidation therapy followed by maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) or myelodysplastic…
Primary Objective:* To compare event-free survival (EFS) between AG-120 + azacitidine and placebo + azacitidine. Key Secondary Objectives:* To compare the complete remission (CR) rate between AG-120 + azacitidine and placebo + azacitidine. EFS is…
The primary objective of this study is to:• Determine the safety and tolerability of AG-120 and AG-221 when administered with induction and consolidation therapy in patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate…
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…
To determine the most effective drug (iNO or IV sildenafil) for the treatment of PH in newborns with CDH and to reach evidence based dosing of this drug. Subsequently this drug will be added to the international guidelines for the treatment of…
Phase 1b Dose-finding Stage Primary Objectives· To assess the safety and tolerability of the combination treatments of oral AG-120 when administered with subcutaneous (SC) azacitidine and oral AG-221 when administered with SC azacitidine in subjects…