INNOVATION: Four-year safety and effectiveness of the INCRAFT® AAA Stent Graft for endovascular repair of abdominal aortic aneurysms.

BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent Graft system (Cordis Corp, Milpitas, CA), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. METHODS: The INNOVATION Trial is the prospective, first-in-human, multicenter trial to evaluate the safety and effectiveness of the INCRAFT® System. Patients underwent annual clinical and CTA examination as part of the study protocol. The INCRAFT® AAA Stent Graft System is a customizable tri-modular design, with an ultra-low profile (14Fr) delivery system. Patient were treated under approved protocol, the prescribed clinical and imaging follow-up at annually through 5 years. Results analyzed and adjudicated by a clinical events committee, independent core laboratory, and a data safety and monitoring board. This manuscript reports results through 4 years of follow up. RESULTS: A total of 60 patients were enrolled in the trial, all of whom were successfully treated. Follow-up rates at 1 and 4 years were 93% (56/60) and 85% (51/60), respectively. All-cause mortality at 4 years was 17.6% and no death was AAA-, device-, or procedure-related. The secondary reintervention rate at 1 year was 4.6%, primarily the result of stent thrombosis. In total, 10 patients required 13 post-procedure interventions within 4 years of follow up (2 to repair a type I endoleak, 4 to repair a type II endoleak, 1 for stent thrombosis, 1 for renal stenosis, 1 for aneurysm enlargement, 2 for limb migration and 2 for prosthesis stenosis or occlusion). There were 4 cases (10%) of aneurysm enlargement reported at the 4 year follow up. At 4 years, 38/39 patients were free from type I and III endoleaks. There were no proximal type I or type III endoleaks at 4 year follow up. Core laboratory evaluation of the postoperative imaging studies indicated absence of endograft migration while a single fracture was demonstrated without any clinical sequelae. CONCLUSIONS: The INCRAFT® AAA Stent Graft System provides a minimally invasive and durable solution for patients undergoing EVAR that has been associated with a low frequency of device related events through 4 years of follow-up.