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

G Pratesi, C Pratesi, R Chiesa, G Coppi, D Scheinert, JS Brunkwall, S Van Der Meulen, G Torsello

Research output: Contribution to journalArticle

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 IN CRAF T® 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 ty pe 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. © 2016 Edizioni Minerva Medica.
Original languageEnglish
Pages (from-to)650-657
Number of pages8
JournalJournal of Cardiovascular Surgery
Volume58
Issue number5
Publication statusPublished - 2017

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Stents
Endoleak
Transplants
Safety
Equipment and Supplies
Aneurysm
Pathologic Constriction
Thrombosis
Clinical Trials Data Monitoring Committees
Prosthesis Failure
Abdominal Aortic Aneurysm
Clinical Protocols
Multicenter Studies
Extremities
Kidney
Mortality

Cite this

Pratesi, G., Pratesi, C., Chiesa, R., Coppi, G., Scheinert, D., Brunkwall, JS., ... Torsello, G. (2017). The INNOVATION Trial: Four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair. Journal of Cardiovascular Surgery, 58(5), 650-657.

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.

In: Journal of Cardiovascular Surgery, Vol. 58, No. 5, 2017, p. 650-657.

Research output: Contribution to journalArticle

Pratesi, G, Pratesi, C, Chiesa, R, Coppi, G, Scheinert, D, Brunkwall, JS, Van Der Meulen, S & Torsello, G 2017, 'The INNOVATION Trial: Four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair', Journal of Cardiovascular Surgery, vol. 58, no. 5, pp. 650-657.
Pratesi, G ; Pratesi, C ; Chiesa, R ; Coppi, G ; Scheinert, D ; Brunkwall, JS ; Van Der Meulen, S ; Torsello, G. / The INNOVATION Trial: Four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair. In: Journal of Cardiovascular Surgery. 2017 ; Vol. 58, No. 5. pp. 650-657.
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abstract = "BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT{\circledR} 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{\circledR} System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The IN CRAF T{\circledR} 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 ty pe 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{\circledR} 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. {\circledC} 2016 Edizioni Minerva Medica.",
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T1 - The INNOVATION Trial: Four-year safety and effectiveness of the INCRAFT® AAA Stent-Graft System for endovascular repair

AU - Pratesi, G

AU - Pratesi, C

AU - Chiesa, R

AU - Coppi, G

AU - Scheinert, D

AU - Brunkwall, JS

AU - Van Der Meulen, S

AU - Torsello, G

PY - 2017

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N2 - 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 IN CRAF T® 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 ty pe 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. © 2016 Edizioni Minerva Medica.

AB - 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 IN CRAF T® 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 ty pe 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. © 2016 Edizioni Minerva Medica.

M3 - Article

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SP - 650

EP - 657

JO - Journal of Cardiovascular Surgery

JF - Journal of Cardiovascular Surgery

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