3 results
To prospectively collect and assess global safety and efficacy data on the IN.PACT Admiral* Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries in *real world* patient population.
Primary:* Phase I: to establish the recommended phase II dose (RP2D) of BCT-100 in children andyoung adults as assessed by dose limiting toxicity (DLT) and complete arginine depletion.* Phase II: to determine the activity of single agent BCT-100…
Primary objective:To improve the PET negativity after two cycles of immuno-chemotherapyPrimary efficacy endpoint:PET 2 assessment according to the five-point scale Deauville criteria (Negative = 1, 2, 3 and Positive = 4, 5), based on central review.…