OBJECTIVE: The authors report the experience of a single investigational center involving two Phase I and a Phase II clinical trials approved by the Food and Drug Administration (FDA) for the transfemoral implantation of woven Dacron grafts for abdominal aortic aneurysms. SUMMARY BACKGROUND DATA: In 1993, EndoVascular Technologies, Inc. ([EVT]; Menlo Park, CA), began an FDA-approved clinical trial of repair of abdominal aortic aneurysms by transfemoral placement of a tube endograft. Subsequently, a bifurcated endograft trial was started. This the first single institution report using the EVT endograft for both tube and bifurcated aortic replacement. METHODS:Seventeen patients were enrolled in two Phase I and one Phase II clinical trials. The Phase I tube graft trial and the Phase I bifurcated graft trial were nonrandomized studies. The Phase II tube graft trial consisted of a randomized prospective control trial of open endoaneurysmorrhaphy versus transfemoral placement of an endograft. RESULTS:Seventeen patients were enrolled in the trial. The graft was placed successfully in all but one patient. Five patients randomized to open procedure and one declined to participate. Eleven patients with endografts are available for follow-up. One graft has been explanted for attachment system migration. One patient is a late failure because of persistent filling of the aneurysm sac. CONCLUSION:Transfemoral placement of an endovascular graft is a viable and effective treatment of abdominal aortic aneurysms in the short term. Use of a bifurcated endograft will open the procedure to more patients. The ideal attachment system and graft material await long-term implantation follow-up.
RCT Entities:
OBJECTIVE: The authors report the experience of a single investigational center involving two Phase I and a Phase II clinical trials approved by the Food and Drug Administration (FDA) for the transfemoral implantation of woven Dacron grafts for abdominal aortic aneurysms. SUMMARY BACKGROUND DATA: In 1993, EndoVascular Technologies, Inc. ([EVT]; Menlo Park, CA), began an FDA-approved clinical trial of repair of abdominal aortic aneurysms by transfemoral placement of a tube endograft. Subsequently, a bifurcated endograft trial was started. This the first single institution report using the EVT endograft for both tube and bifurcated aortic replacement. METHODS: Seventeen patients were enrolled in two Phase I and one Phase II clinical trials. The Phase I tube graft trial and the Phase I bifurcated graft trial were nonrandomized studies. The Phase II tube graft trial consisted of a randomized prospective control trial of open endoaneurysmorrhaphy versus transfemoral placement of an endograft. RESULTS: Seventeen patients were enrolled in the trial. The graft was placed successfully in all but one patient. Five patients randomized to open procedure and one declined to participate. Eleven patients with endografts are available for follow-up. One graft has been explanted for attachment system migration. One patient is a late failure because of persistent filling of the aneurysm sac. CONCLUSION: Transfemoral placement of an endovascular graft is a viable and effective treatment of abdominal aortic aneurysms in the short term. Use of a bifurcated endograft will open the procedure to more patients. The ideal attachment system and graft material await long-term implantation follow-up.
Authors: W J Quiñones-Baldrich; D H Deaton; R S Mitchell; G Berry; A Piplani; D Quiachon; W H Edwards; W S Moore Journal: J Vasc Surg Date: 1995-10 Impact factor: 4.268