Martin E C, Katzen B T, Benenati J F, Diethrich E B, Dorros G, Graor R A, Horton K M, Iannone L A, Isner J M, Ramee S R
Department of Radiology, Columbia-Presbyterian Medical Center, New York, NY 10032, USA.
J Vasc Interv Radiol. 1995 Nov-Dec;6(6):843-9. doi: 10.1016/s1051-0443(95)71198-8.
To report the results of the FDA phase II, multicenter trial of the Wallstent in the iliac and femoral arteries.
Two hundred twenty-five patients entered the trial. Stents were placed in the iliac system in 140 patients and in the femoral system in 90 (five patients required both iliac and femoral stents). Clinical patency was measured over 2 years by means of life-table analysis with use of clinical and hemodynamic data and the Rutherford scale. Angiographic patency was measured at 6 months.
In the iliac system the primary clinical patency was 81% at 1 year and was 71% at 2 years. The secondary clinical patency was 91% and 86%, respectively. The 6-month angiographic patency was 93%. In the femoral system the primary clinical patency was 61% at 1 year and 49% at 2 years. The secondary patency was 84% and 72%, respectively. The 6-month angiographic patency was 80%.
The results are similar to those with the Palmaz stent in the iliac system and with angioplasty alone in the iliac and femoral systems.
报告美国食品药品监督管理局（FDA）关于Wallstent在髂动脉和股动脉应用的多中心II期试验结果。
225例患者进入该试验。140例患者在髂动脉系统置入支架，90例患者在股动脉系统置入支架（5例患者髂动脉和股动脉均需置入支架）。通过使用临床和血流动力学数据以及卢瑟福分级的生命表分析，在2年时间内对临床通畅情况进行测量。在6个月时测量血管造影通畅情况。
在髂动脉系统，1年时主要临床通畅率为81%，2年时为71%。次要临床通畅率分别为91%和86%。6个月时血管造影通畅率为93%。在股动脉系统，1年时主要临床通畅率为61%，2年时为49%。次要通畅率分别为84%和72%。6个月时血管造影通畅率为80%。
这些结果与Palmaz支架在髂动脉系统以及单纯血管成形术在髂动脉和股动脉系统的结果相似。
