B. Braun Melsungen AG (B. Braun), a supplier of products for anesthesia, intensive medicine, cardiology market, is planning to complete the phase III trial entitled INDICOR for SeQuent Please by April 2012. The trial is being conducted in India with an estimated enrollment of 125. The study Principal Investigator is Upendra kAUL, Dr. from Fortis Flt.Lt.Rajan Dhall Hospital, New Delhi, India
The INDICOR study is a controlled, prospective, multicenter, randomized, two arm phase-II real world study assessing the acute, 6 months, and 12 months and 3 year outcome of cobalt-chromium stent (Coroflex Blue) deployment followed by Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) and of Paclitaxel-eluting PTCA-balloon dilatation (SeQuent Please) followed by cobalt-chromium stent (Coroflex Blue) deployment for the treatment of de-novo and restenotic lesions in native coronary arteries.
SeQuent Please drug eluting balloon catheter delivers drugs directly to the lesion during angioplasty. The matrix technology of the SeQuent Please is more effective than a simple drug coating of a balloon. After the inflation, the matrix will dissolve immediately so that no material is left behind that could potentially lead to complications later.
The official title or the study is “The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent to Treat Coronary Artery Disease in a Real World Scenario”.