First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial

OBJECTIVE: This multicenter, prospective, nonrandomized trial was undertaken to evaluate the first-in-human experience with the INCRAFT endograft (Cordis Corporation, Bridgewater, NJ), an ultralow-profile trimodular bifurcate device for the repair of abdominal aortic aneurysms. METHODS: Patients with asymptomatic infrarenal abdominal aortic aneurysms were eligible for enrollment in the trial. Anatomic eligibility criteria included a proximal aortic neck at least 15 mm in length and up to 27 mm in diameter, and an aortic bifurcation ≥18 mm in diameter. Iliofemoral access vessels were required to be large enough to accept the 14F (4.7 mm) outer diameter of the delivery system. The primary efficacy end point was technical success, defined by successful device deployment during the conclusion of the procedure at the desired location without a type I, III, or IV endoleak. The primary safety end point was defined by the absence of a type I, III, or IV endoleak or a device- or procedure-related major adverse event at the 1-month follow-up point. RESULTS: Over a 16-month period divided into two different phases, 57 men and three women with a mean age of 74.4 ± 6.9 years were enrolled at three German and three Italian centers. A percutaneous approach was used in 36 patients (60%). Successful graft deployment at the desired location was achieved in 59 patients (98%). A single patient had successful deployment of the device although it was located more distally than planned. Technical success was achieved in 54 patients (90%); one patient had a type I endoleak, four had type IV endoleaks, and one had an endoleak of undetermined origin. The primary safety end point was met in 56 of the 58 patients (97%) with complete core laboratory data at 1 month; two patients had type I endoleaks. There were no type III or IV endoleaks and no device or procedure-related major adverse events at 1 month. No limb thromboses or stent fractures were noted on postoperative imaging studies and no patient required rehospitalization, a secondary procedure, or open surgical conversion through 1 month of follow-up. CONCLUSIONS: The INCRAFT endograft device holds promise as an innovative alternative to currently marketed devices and broadens the eligibility for endovascular aneurysm repair. More definitive observations will be generated as longer-term data from this trial become available.