Universität zu Köln

Pratesi, Giovanni, Pratesi, Carlo, Chiesa, Roberto, Coppi, Gioacchino, Scheinert, Dierk, Brunkwall, Jan S., van der Meulen, Stefaan and Torsello, Giovanni (2017). The INOVATION Trial: four-year safety and effectiveness of the INCRAFT (R) AAA Stent-Graft System for endovascular repair. J. Cardiovasc. Surg., 58 (5). S. 650 - 658. TURIN: EDIZIONI MINERVA MEDICA. ISSN 1827-191X

Full text not available from this repository.

Abstract

BACKGROUND: This paper reports the 4-year safety and effectiveness of the INCRAFT (R) AA 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 (R) System. Patients underwent annual clinical and computed tomography angiography examination as part of the study protocol. The INCRAFT (R) 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 AA-, 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 II endoleaks. There were no proximal type I or type II 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 (R) AA 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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Pratesi, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED Pratesi, Carlo UNSPECIFIED UNSPECIFIED UNSPECIFIED Chiesa, Roberto UNSPECIFIED UNSPECIFIED UNSPECIFIED Coppi, Gioacchino UNSPECIFIED UNSPECIFIED UNSPECIFIED Scheinert, Dierk UNSPECIFIED UNSPECIFIED UNSPECIFIED Brunkwall, Jan S. UNSPECIFIED UNSPECIFIED UNSPECIFIED van der Meulen, Stefaan UNSPECIFIED UNSPECIFIED UNSPECIFIED Torsello, Giovanni UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-215578
DOI:	10.23736/S0021-9509.17.09305-3
Journal or Publication Title:	J. Cardiovasc. Surg.
Volume:	58
Number:	5
Page Range:	S. 650 - 658
Date:	2017
Publisher:	EDIZIONI MINERVA MEDICA
Place of Publication:	TURIN
ISSN:	1827-191X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ENDOPROSTHESIS Multiple languages Cardiac & Cardiovascular Systems; Surgery; Peripheral Vascular Disease Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/21557