Setting up of a multicentric European registry dealing with type B dissections in chronic and acute phases with thoracic EndoFit® devices

Aim. This registry aims at evaluating the use and efficacy of the EndoFit stent graft (LeMaitre Vascular, Burlington MA, USA) for the treatment of acute and chronic aortic type B dissections. Methods. Indications for treatment are: recurrent pain, persistent hypertension, serious organ malperfusion in patients with acute or subacute type B aortic dissection and progression of aneurysm size despite maximal medical therapy in patient with chronic type B dissection. Exclusion criteria are: age under 18 years old, pregnancy, coagulopathy or bleeding disorders, connective tissue disease. Straight or tapered EndoFit stent graft will be used in acute or chronical dissection respectively. Results. The primary endpoint is the assessment of the safety and the efficacy of the EndoFit® Thoracic Endoluminal Stent Graft in the exclusion of the thoracic aortic false lumen in acute and chronic type B aortic dissections. The assessment includes: technical success, thrombosis of the thoracic false lumen at 6 months, rate of aorto-enteric, aorto-esophageal and aorto-bronchial fistula, serious adverse events including death, stroke, paraplegia, myocardial infarction, multi-organ failure and renal insufficiency. Secondary endpoints are: the technical feasibility of device implantation in 2 different shapes (straight for acute dissection and tapered for chronic dissection), the technical feasibility of endovascular placement of tapered grafts in vessels of different size and shape, the integrity of the device fabric and wire structure, the occurrence of device migration, the patient's neurological, cardiac and cardiovascular status, the blood flow supply to abdominal and visceral organs arteries and any secondary intervention including stent-graft extension, coiling or surgical conversion. One hundred patients enrolled have been defined to allow reliable findings and results. Conclusion. The DEDICATED is the first prospective data collection registry focusing on the role of tapered stent-grafts in chronic aortic dissection and their efficacy in excluding the dissected thoracic false lumen.