Successful patient recruitment in the CONSEQUENT Trial
The CONSEQUENT Trial investigated B. Braun’s novel peripheral drug coated balloon technology SeQuent® Please OTW.
Berlin (Germany). B. Braun Vascular Systems announces the successful patient recruitment of it landmark CONSEQUENT Trial on April 15, 2015. The coordinating investigators Prof. Thomas Albrecht (Vivantes Neukölln Berlin) and Prof. Gunnar Tepe (RoMed Rosenheim) expect first results of this novel peripheral drug coated balloon (DCB) for above and below the knee lesions at the LINC Congress 2016.
The CONSEQUENT Trial investigated the 6-month late lumen loss (primary efficacy endpoint) of B. Braun’s flagship product SeQuent® Please OTW which was developed in cooperation with the Charité Berlin (Prof. Ulrich Speck, InnoRa). “We are confident that we can repeat our tremendous success in the coronary field with the market leading SeQuent® Please drug coated balloon” says Dr. Michael Boxberger director of Medical Scientific Affairs and Regulatory Affairs at B. Braun Vascular Systems. The CONSEQUENT Trial is a randomized, prospective, multi-center study and consisted of 150 patients (75 per group) that were either treated with the optimized peripheral DCB Technology or the analogous uncoated balloon.
Based on extensive experience from B. Braun’s cooperation with the National Institute of Clinical Excellence (NICE) in the UK , the CONSEQUENT Trial design will fulfill increasing demands from reimbursement agencies worldwide to demonstrate the cost-efficacy of SeQuent Please OTW in peripheral artery occlusive disease. To execute and advance our state of the art post-market surveillance strategies that lead in the coronary field to a class IA recommendation by the European Society of Cardiology, a likewise approach is intended for the peripheral field. For this reason, additionally to the CONSEQUENT Trial a clinical registry will accompany the successful commercialization of SeQuent Please OTW. This trial is also the outcome of a highly fruitful cooperation with our CRO partner at the Charité Berlin which has most experience in trials that investigate peripheral artery occlusive disease.