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Titolo:
The talent endoluminal AAA stent-graft system. Report of the phase I USA trial, and summary of worldwide experience
Autore:
Criado, FJ; Fry, PD; Machan, LS; Twena, M; Patten, P;
Indirizzi:
UnionSAem Hosp Helix Hlth, Div Vasc Surg, Endovasc Program, Baltimore, MD U Union Mem Hosp Helix Hlth Baltimore MD USA vasc Program, Baltimore, MD U
Titolo Testata:
JOURNAL DES MALADIES VASCULAIRES
fascicolo: 5, volume: 23, anno: 1998,
pagine: 371 - 373
SICI:
0398-0499(199812)23:5<371:TTEASS>2.0.ZU;2-B
Fonte:
ISI
Lingua:
ENG
Soggetto:
ANEURYSM EXCLUSION; CLASSIFICATION; ENDOLEAK; REPAIR;
Keywords:
abdominal aortic aneurysm; bifurcated Talent stent graft;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
6
Recensione:
Indirizzi per estratti:
Indirizzo: Criado, FJ 3333 N Calvert St,Suite 570, Baltimore, MD 21218 USA 3333 N Calvert St,Suite 570 Baltimore MD USA 21218 D 21218 USA
Citazione:
F.J. Criado et al., "The talent endoluminal AAA stent-graft system. Report of the phase I USA trial, and summary of worldwide experience", J MAL VASC, 23(5), 1998, pp. 371-373

Abstract

In the United States, the Phase I Feasibility Study under IDE G970065 was approved by the Food and Drug Administration on 04/11/97. The approved protocol called for implantation of the bifurcated Talent spring stent-graft system on patients who are high-risk candidates for conventional surgery because of cardio-respiratory, medical, general, or local anatomical reasons which would likely complicate the technical execution of the operation or be accompanied by a high expected mortality rate. Patient enrollment was complete with 16 cases as of September 26, 1997. This was a multicenter experience involving five different sites. This is an ongoing study and patients, of course, will continue to be followed longitudinally. Phase II will likely be approved by the FDA for initiation in January or February of 1998. Standard-risk AAA patients will be entered into the study at this time; comparison with concurrent controls will be used for comparison with conventional surgery.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 01/10/20 alle ore 03:11:06