The talent endoluminal AAA stent-graft system. Report of the phase I USA trial, and summary of worldwide experience.
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.
Criado
F J
FJ
Division of Vascular Surgery/Endovascular Program, Union Memorial Hospital/Helix Health, Baltimore, MD, USA.
Fry
P D
PD
Machan
L S
LS
Twena
M
M
Patten
P
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration