10 results
* 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 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…
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
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,…
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 aim of this study is to evaluate whether the MyTAP can be used as a screening tool to predict treatment success with MAD therapy. This will be evaluated during a 3 month follow-up of the therapy.Secondly, we want to compare the patient…
Primary Objective:* The primary objective is to demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST),…
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…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
Primary: • The primary objective is to determine adjudicated ORR (CR/CR with partial recovery of peripheral blood counts [CRh] + PR + CI) based on modified IWG-MRT-ECNM consensus response criteria in patients with AdvSM treated with avapritinib and…