title: The INNOVATION Trial: four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair.
abstract: BACKGROUND
  This paper reports the 4-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System (Cordis Corp., Milpitas, CA, USA), 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 computed tomography angiography examination as part of the study protocol. The INCRAFT® AAA Stent-Graft System is a customizable tri-modular design, with an ultra-low profile (14-Fr) 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 out of 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.
authors.affiliation: Vascular Surgery Unit, Department of Biomedicine and Prevention, University of Rome Tor Vergata, Rome, Italy - giovanni.pratesi@uniroma2.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pratesi
authors.affiliation: Vascular Surgery Unit, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Pratesi
authors.affiliation: Department of Vascular Surgery, Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Chiesa
authors.affiliation: Department of Vascular Surgery, S. Agostino-Estense Hospital, University of Modena and Reggio Emilia, Baggiovara, Modena, Italy.
authors.forename: Gioacchino
authors.initials: G
authors.lastname: Coppi
authors.affiliation: Department of Interventional Angiology, Faculty of Medicine, University of Leipzig, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: Department of Vascular Surgery, Faculty of Medicine, University Clinic of Cologne, Cologne, Germany.
authors.forename: Jan S
authors.initials: JS
authors.lastname: Brunkwall
authors.affiliation: Syntactx Clinical Research Organization, New York, NY, USA.
authors.forename: Stefaan
authors.initials: S
authors.lastname: van der Meulen
authors.affiliation: St. Franziskus Hospital, Münster, Germany.|University Clinic of Münster, Münster, Germany.
authors.forename: Giovanni
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; D000072226:Computed Tomography Angiography; D018450:Disease Progression; D057867:Endoleak / Q000209:etiology; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005548:Foreign-Body Migration / Q000209:etiology; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000209:etiology; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D012307:Risk Factors; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome