1. Update on the Talent aortic stent-graft: a preliminary report from United States phase I and II trials.
- Author
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Criado FJ, Wilson EP, Fairman RM, Abul-Khoudoud O, and Wellons E
- Subjects
- Angioplasty adverse effects, Angioplasty mortality, Aortic Aneurysm, Abdominal mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Female, Humans, Male, Multicenter Studies as Topic, Prospective Studies, Prosthesis Design, Prosthesis Failure, Risk Factors, Safety, Treatment Outcome, United States, Angioplasty instrumentation, Angioplasty methods, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation methods, Stents adverse effects, Stents standards
- Abstract
Purpose: Phase I and phase II trials were conducted to determine the safety and efficacy of the Talent aortic stent-graft (Medtronic World Medical, Sunrise, Fla) in the treatment of infrarenal abdominal aortic aneurysms (AAA). This is a preliminary report of the technical results and 30-day clinical outcome of these trials., Methods: Multicenter prospective trials were conducted to test the Talent stent-graft in high-risk and low-risk patient populations with AAA, including phase I feasibility and phase II clinical trials. The low-risk study included concurrent surgical controls., Results: In the phase I trial, deployment success was achieved in 92% (23/25 patients), and initial technical success was 78% (18/23 implants without endoleak). The 30-day technical success rate was 96%, with six endoleaks that resolved spontaneously (without need for further intervention); and the 30-day mortality rate was 12% (3/25 patients). The phase II high-risk trial demonstrated a deployment success of 94% (119/127 patients) and an initial technical success of 86% (102/119 implants). The 30-day technical success rate was 96%, and the 30-day mortality rate was 1.5% (2/127 patients). The phase II low-risk trial included a first-generation and a second-generation Talent stent-graft. Deployment success rates were 97% and 99%, respectively, and technical success rates at 30 days were 97% and 96%, respectively. The 30-day mortality rate was 2% in the phase II low-risk first-generation device trial, and the adverse-event rate was 20%. Corresponding figures for the second-generation device were 0% and 1.8%, respectively., Conclusion: The Talent stent-graft can be deployed successfully and achieves endovascular exclusion in a large proportion of patients with AAA. Morbidity and mortality rates are acceptable. One-year clinical results and the comparison with concurrent surgical control subjects remain to be evaluated.
- Published
- 2001
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