title: INCRAFT® Stent-Graft System: one-year outcome of the INNOVATION Trial.
abstract: OBJECTIVE
  Endovascular repair has surpassed open surgical treatment as the most common procedure in patients with abdominal aortic aneurysms (AAA), yet its applicability remains limited to those with aortoiliac anatomy suitable for the introduction and deployment of the devices. The current study was performed to assess the safety and efficacy of INCRAFT® (Cordis Corporation, Bridgewater, NJ), an ultra-low-profile device for the treatment of AAA.
  
  
  METHODS
  The INNOVATION study is a first in human prospective, multicenter trial involving 6 centers in Europe. From March 2010 to June 2011 60 patients with asymptomatic AAA were treated with the INCRAFT® bifurcated Stent-Graft System. The main inclusion criteria were a proximal aortic neck of 15 mm or more in length and up to 27 mm in diameter; iliac landing zones greater than 10 mm in length and between 9 and 18 mm in diameter; an access vessel large enough to accept the 14F outer diameter of the delivery system; and an aortic bifurcation >18 mm in diameter. The primary endpoint was technical success at one-month; one-year safety endpoints included the absence of device- or procedure-related major adverse events; absence of type I or III endoleaks; and maintenance of device integrity through one year of follow-up.
  
  
  RESULTS
  Among 60 patients treated at six centers, the primary endpoint was met in 56 of 58 patients (97%; 95% CI, 88-100%) who came back for one month follow-up, two patients did not come back for their one month follow-up assessments but remained enrolled in the study. Fifty-six had one-year follow-up data showing 100% freedom from aneurysm enlargement with absence of type I and III endoleaks in all patients. There were two patients (3.6%) with a type Ia endoleak which was successfully treated with secondary endovascular intervention in both occasions. Core laboratory evaluation of the postoperative imaging studies documented absence of endograft migration, stent fracture, or limb occlusion. A single patient (1.8%) died within one year due to sepsis unrelated to the AAA.
  
  
  CONCLUSIONS
  The results of the INNOVATION study with the INCRAFT® Stent-Graft are encouraging, with satisfactory clinical outcome and device durability through one-year of follow-up. The INCRAFT® device is a novel ultra-low-profile endograft that holds promise to broaden the patient population eligible for endovascular aneurysm repair.
authors.affiliation: Department of Vascular Surgery Nuovo Ospedale Civile S. Agostino-Estense Baggiovara University of Modena and Reggio Emilia Baggiovara, Modena, Italy - gioachino.coppi@unimore.it.
authors.forename: G
authors.initials: G
authors.lastname: Coppi
authors.forename: M
authors.initials: M
authors.lastname: Njila
authors.forename: G
authors.initials: G
authors.lastname: Coppi
authors.forename: G
authors.initials: G
authors.lastname: Saitta
authors.forename: R
authors.initials: R
authors.lastname: Silingardi
authors.forename: C
authors.initials: C
authors.lastname: Pratesi
authors.forename: R
authors.initials: R
authors.lastname: Chiesa
authors.forename: D
authors.initials: D
authors.lastname: Scheinert
authors.forename: J S
authors.initials: JS
authors.lastname: Brunkwall
authors.forename: G
authors.initials: G
authors.lastname: Torsello
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001027:Aortography / Q000379:methods; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications / Q000209:etiology; D011446:Prospective Studies; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome