title: Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Vascular Surgery, St. Franziskus Hospital and University Clinic of Muenster, Muenster, Germany. Electronic address: giovanni.torsello@ukmuenster.de.
authors: Giovanni
authors: G
authors: Torsello
authors: Department of Cardiology and Angiology, Park Hospital Leipzig, Leipzig, Germany.
authors: Dierk
authors: D
authors: Scheinert
authors: Department of Vascular Surgery, University Clinic of Cologne, Cologne, Germany.
authors: Jan S
authors: JS
authors: Brunkwall
authors: Department of Vascular Surgery, San Raffaele Scientific Institute, Milan, Italy.
authors: Roberto
authors: R
authors: Chiesa
authors: Department of Vascular Surgery Nuovo Ospedale Civile S. Agostino-Estense Baggiovara University of Modena and Reggio Emilia Baggiovara, Modena, Italy.
authors: Gioachino
authors: G
authors: Coppi
authors: Department of Vascular Surgery, University of Florence, Florence, Italy.
authors: Carlo
authors: C
authors: Pratesi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000175:diagnosis / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D057867:Endoleak / Q000209:etiology / Q000628:therapy; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000628:therapy; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome