An in situ adjustable endovascular graft for the treatment of abdominal aortic aneurysms

J Vasc Surg. 2002 Jan;35(1):114-9. doi: 10.1067/mva.2002.119748.


Twenty-nine patients underwent placement of the Teramed Ariba Endovascular Graft System (Maple Grove, Minn) as part of a European Feasibility study (14 patients) and a US phase I trial (15 patients). Salient features of this modular endograft system include a crimped seamless polyester bifurcation graft supplied in three diameters and three iliac limb lengths, three types of nitinol stents including a suprarenal stent with aortic barbs, a flexible delivery system capable of controlled incremental sheath retraction, a flexible tapered lead balloon, and a telescoping technique for adjusting the length of graft coverage during surgery over a range of 3 cm. Twenty-eight of the 29 patients met the primary objective of this evaluation, which was to confirm the safety of the system, defined as the absence of major device-related adverse events and type I, III, or IV endoleaks within 1 month of implantation. Three major adverse events occurred within 1 month of discharge: renal failure, which was related to deployment of the device close to the renal arteries; pulmonary edema, which was related to the procedure but not the device; and peripheral ischemia, which was related to the patient's pre-existing condition. Seven patients had type II endoleaks noted by means of computed tomography scanning at 1 month; the endoleaks were identified by means of angiography and classified at the time of surgery. There were no deaths, aneurysm ruptures, stent-graft migrations, stent fractures, graft ruptures, graft thromboses, or surgical conversions at 1 month. This early clinical experience indicates that the Ariba Bifurcated Endovascular System can be safely implanted.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Aged
  • Aged, 80 and over
  • Angiography
  • Aorta, Abdominal / diagnostic imaging
  • Aorta, Abdominal / surgery
  • Aortic Aneurysm, Abdominal / diagnostic imaging
  • Aortic Aneurysm, Abdominal / surgery*
  • Blood Vessel Prosthesis Implantation / instrumentation*
  • Endoscopy*
  • Equipment Design / instrumentation
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Prosthesis Fitting
  • Stents*
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Vascular Surgical Procedures / instrumentation*