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

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. 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. 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. 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.

Scheinert D ，Pratesi C ，Chiesa R ，Coppi G ，Brunkwall JS ，Klarenbeek G ，Cebrian A ，Torsello G ... -  《-》

Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms.

This study evaluated the 2-year safety and effectiveness of the European First-in-Human INNOVATION trial for the INCRAFT AAA Stent Graft system (Cordis Corp, Bridgewater, NJ), an ultra-low-profile device for the treatment of abdominal aortic aneurysms. From March 2010 to June 2011, the INNOVATION prospective multicenter trial involving six centers in Europe enrolled and treated 60 asymptomatic patients (95% male; mean age, 74.4 ± 6.9 years) with the INCRAFT System. Main inclusion criteria included proximal aortic neck length of 15 mm or more with a diameter up to 27 mm; distal iliac landing zones with a length greater than 10 mm and a diameter between 9 and 18 mm; and aortic bifurcation >18 mm in diameter and access vessels large enough to accept the 14F outer diameter of the delivery system. The primary end point was technical success at 1 month; 2-year safety end points included the absence of device- or procedure-related major adverse events, absence of type I or III endoleaks, and maintenance of device integrity through 2 years of follow-up. Study oversight was provided by a Data Safety Monitoring Board with event adjudication by a Clinical Events Committee and imaging analysis by an independent core laboratory. Of 60 successfully treated patients, two did not come back for their 1-month evaluation but remained enrolled in the study; 56 were evaluated at 1 year and 52 at 2 years. Of the 58 patients, 56 met the 1-month primary safety and effectiveness end point (97%; 95% confidence interval, 88%-100%). All patients were free from aneurysm enlargement through 2 years. There were no type I or III endoleaks at the 2-year time point. All-cause mortality at 2 years was 11.5%, and no death was device or procedure related. In total, three patients required a postprocedure intervention, two to repair a type I endoleak and one for limb occlusion. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration and stent fractures in all patients. The INCRAFT AAA Stent Graft System provides a durable solution for patients with abdominal aortic aneurysms, with a low frequency of device-related events through 2 years of follow-up.

Torsello G ，Scheinert D ，Brunkwall JS ，Chiesa R ，Coppi G ，Pratesi C ... -  《-》

INCRAFT® Stent-Graft System: one-year outcome of the INNOVATION Trial.

Coppi G ，Njila M ，Coppi G ，Saitta G ，Silingardi R ，Pratesi C ，Chiesa R ，Scheinert D ，Brunkwall JS ，Torsello G ... -  《-》

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system.

Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif). This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States. A total of 155 patients were enrolled in the trial (mean age, 73 ± 8 years; male, 93.5%; mean AAA diameter, 53.6 ± 7.9 mm). The Aptus endograft is a two-component system: a multilumen, modular endograft with two docking limbs (Aptus Endograft System) and the Heli-FX Aortic Securement System comprising an electronically controlled applier (Heli-FX Applier) with helical EndoAnchors provided in a cassette and a deflectable sheath (Heli-FX Guide) designed for delivery of the applier to the target location for EndoAnchor implantation. The main eligibility criteria included proximal neck length of ≥12 mm, diameter of 19 to 29 mm, and infrarenal angulation of ≤60 degrees. The primary safety end point was freedom from major adverse events at 30 days, and the primary effectiveness end point was successful aneurysm treatment at 12 months. Thrombus-related events (TRE) were defined as limb occlusion or thromboembolism from the endograft. Subjects were observed for a median of 4.2 years, with imaging end points analyzed by a core laboratory and adverse events adjudicated by a clinical events committee. Among 155 enrolled subjects, 153 (98.7%) underwent successful implantation of the Aptus endograft and a median of five EndoAnchors; two subjects were converted to open surgical repair during the initial procedure. Overall, the primary safety and effectiveness end points were met in 98.1% and 97.4% of the subjects, respectively. Aneurysm-related mortality was 0.6%, with one postdischarge cardiac death 18 days after implantation. There were no AAA ruptures. There were no fractures of stents or EndoAnchors. There was one type I endoleak and one type III endoleak. Stent graft migration was noted in five subjects, none associated with sac enlargement, type I endoleak, or EndoAnchor dislocation from the endograft. AAA sac shrinkage of ≥5 mm at 1, 2, and 3 years was observed in 60.3%, 72.9%, and 81.7%, respectively. Sixty-one subjects (39.4%) experienced 113 TRE, associated with 80 reinterventions (in 58 subjects) unassociated with limb loss or death. A root cause analysis of TRE identified small, out-of-specification docking limbs with graft infolding and high local shear, resulting in thrombus formation within the endograft with subsequent distal embolization in some cases. Early results of the Aptus endograft trial met its safety and effectiveness end points; however, a high rate of TRE was observed because of manufacturing discrepancies. The findings confirm a low rate of type I and type III endoleaks, migration, and non-TRE reintervention with a high rate of aneurysm sac regression during midterm follow-up.

Mehta M ，Henretta J ，Glickman M ，Deaton D ，Naslund TC ，Gray B ，McCann R ，Jordan W ，Fairman R ... -  《-》

The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.

Pratesi G ，Pratesi C ，Chiesa R ，Coppi G ，Scheinert D ，Brunkwall JS ，van der Meulen S ，Torsello G ... -  《-》