Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac from blood flow and pressure.

An arterial anuerysm is a permanent, localized dilatation of an artery with an increase in diameter ≥ 50% larger than the normal artery. Although any artery may develop an aneurysm, they are most commonly seen in the abdominal aorta, the thoracic aorta, the popliteal artery and the common iliac artery. The use of intravascular stents and endoluminal grafts to exclude natural arterial aneurysms or treat occlusive vascular lesions has been evaluated in a number of preclinical studies. Endovascular stent graft implantation obviates the need for abdominal surgery by using the peripheral arteries as a route to the aneurysm, and stents provide a means of graft attachment other than sutures. The goal of endoluminal grafting is the same as that of conventional repair and allows insertion of a resilient conduit between the ends of the aneurysm to exclude it from the circulation and prevent rupture of the aneurysm. This is a Phase 2 Clinical Study of the Bifurcated PowerLink System (Endoluminal Graft) for the treatment of abdominal infrarenal aorto-iliac aneurysmal disease (AAA). Diagnostic imaging methods such as Spiral CT Scans, angiography, ultrasound and fluoroscopy imaging will be used to choose the sites for placement of the device and to assure precise deployment. The Delivery Catheter allows endovascular placement of the Device (endoluminal graft) via either retrograde (femoral or iliac arteries) or antegrade (brachial arteries) approaches. The Endoluminal Graft (ELG) is a self-expanding metal alloy stent cage, which is covered on the outside by a thin walled ePTPE graft material. The graft material is fully supported throughout the entire ELG length. The ELG is also available in a bifurcated configuration. The bifurcated delivery catheter is available in various diameters and working lengths. The catheter consists of an introducer sheath with homeostatic vavle and an inner shaft. The inner shaft is an obturator with a tapered tip connected to a rear obturator by means of a hypotube. The main body of the ELG is compressed around the hypotube then loaded into the Delivery Catheter. The contralateral and ipsilateral limbs of the ELG are compressed in their respective limb covers and loaded into the Delivery Catheter. The inner shaft accommodates a standard .035 inch guidewire. The concurrent surgical control and test patients' participation in the Study will include enrollment, the Investigational Device procedure or surgical repair and follow-up period. Patient data will be collected during: pre-operative, operative and post-operative follow-up at discharge and at 1 month. Long term follow-up for both the concurrent surgical controls and test patients will continue for 6 and 12 months to support a PMA. Extended follow-up may be required until the Investigational Device is approved under a PMA, or up to 5 years follow-up under Post Market Surveillance requirements.

Major complications: myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, stroke or death

Inclusion Criteria: ≥ 18 years old Informed consent understood and signed Will comply with post-treatment follow-up requirements Candidate for conventional open surgical repair Anatomic Inclusion Criteria: Aneurysm is ≥ 4.0 cm in outer diameter or Saccular aneurysm ≥ 3.0 cm in outer diameter or Aneurysm ≥ twice the normal aortic outer diameter or rapidly growing aneurysm (≥ 5 mm over 6 months) Exclusion Criteria: Life expectancy < 2 years Participating in another clincal research study Pregnant or lactating women Acutely ruptured or leaking aneurysm, or vascular injury due to trauma Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study. Contrast medium or anticoagulation drugs are contraindicated Coagulopathy or bleeding disorder Active systemic or localized groin infection Inferior mesenteric artery is indispensable Connective tissue disease (e.g. Marfan's Syndrome) Creatinine level > 1.7 mg/dl Thrombus at implantation sites

Bickerstaff LK, Hollier LH, Van Peenen HJ, Melton LJ 3rd, Pairolero PC, Cherry KJ. Abdominal aortic aneurysms: the changing natural history. J Vasc Surg. 1984 Jan;1(1):6-12.

Castleden WM, Mercer JC. Abdominal aortic aneurysms in Western Australia: descriptive epidemiology and patterns of rupture. Br J Surg. 1985 Feb;72(2):109-12. doi: 10.1002/bjs.1800720213.

Lilienfeld DE, Gunderson PD, Sprafka JM, Vargas C. Epidemiology of aortic aneurysms: I. Mortality trends in the United States, 1951 to 1981. Arteriosclerosis. 1987 Nov-Dec;7(6):637-43. doi: 10.1161/01.atv.7.6.637.

Bickerstaff LK, Pairolero PC, Hollier LH, Melton LJ, Van Peenen HJ, Cherry KJ, Joyce JW, Lie JT. Thoracic aortic aneurysms: a population-based study. Surgery. 1982 Dec;92(6):1103-8.

McFarlane MJ. The epidemiologic necropsy for abdominal aortic aneurysm. JAMA. 1991 Apr 24;265(16):2085-8.

Collin J, Araujo L, Walton J. How fast do very small abdominal aortic aneurysms grow? Eur J Vasc Surg. 1989 Feb;3(1):15-7. doi: 10.1016/s0950-821x(89)80102-1.

Bernstein EF, Chan EL. Abdominal aortic aneurysm in high-risk patients. Outcome of selective management based on size and expansion rate. Ann Surg. 1984 Sep;200(3):255-63. doi: 10.1097/00000658-198409000-00003.

Delin A, Ohlsen H, Swedenborg J. Growth rate of abdominal aortic aneurysms as measured by computed tomography. Br J Surg. 1985 Jul;72(7):530-2. doi: 10.1002/bjs.1800720709.

Cronenwett JL, Murphy TF, Zelenock GB, Whitehouse WM Jr, Lindenauer SM, Graham LM, Quint LE, Silver TM, Stanley JC. Actuarial analysis of variables associated with rupture of small abdominal aortic aneurysms. Surgery. 1985 Sep;98(3):472-83.

Brown PM, Pattenden R, Gutelius JR. The selective management of small abdominal aortic aneurysms: the Kingston study. J Vasc Surg. 1992 Jan;15(1):21-5; discussion 25-7. doi: 10.1067/mva.1992.33840.

Guirguis EM, Barber GG. The natural history of abdominal aortic aneurysms. Am J Surg. 1991 Nov;162(5):481-3. doi: 10.1016/0002-9610(91)90266-g.

Ouriel K, Green RM, Donayre C, Shortell CK, Elliott J, DeWeese JA. An evaluation of new methods of expressing aortic aneurysm size: relationship to rupture. J Vasc Surg. 1992 Jan;15(1):12-8; discussion 19-20. doi: 10.1067/mva.1992.32982.

Limet R, Sakalihassan N, Albert A. Determination of the expansion rate and incidence of rupture of abdominal aortic aneurysms. J Vasc Surg. 1991 Oct;14(4):540-8. doi: 10.1067/mva.1991.30047.

Nevitt MP, Ballard DJ, Hallett JW Jr. Prognosis of abdominal aortic aneurysms. A population-based study. N Engl J Med. 1989 Oct 12;321(15):1009-14. doi: 10.1056/NEJM198910123211504.

Ingoldby CJ, Wujanto R, Mitchell JE. Impact of vascular surgery on community mortality from ruptured aortic aneurysms. Br J Surg. 1986 Jul;73(7):551-3. doi: 10.1002/bjs.1800730711.

Crawford ES, DeNatale RW. Thoracoabdominal aortic aneurysm: observations regarding the natural course of the disease. J Vasc Surg. 1986 Apr;3(4):578-82. doi: 10.1067/mva.1986.avs0030578.

Dotter CT. Transluminally-placed coilspring endarterial tube grafts. Long-term patency in canine popliteal artery. Invest Radiol. 1969 Sep-Oct;4(5):329-32. doi: 10.1097/00004424-196909000-00008. No abstract available.

Cragg A, Lund G, Rysavy J, Castaneda F, Castaneda-Zuniga W, Amplatz K. Nonsurgical placement of arterial endoprostheses: a new technique using nitinol wire. Radiology. 1983 Apr;147(1):261-3. doi: 10.1148/radiology.147.1.6828742.

Maass D, Zollikofer CL, Largiader F, Senning A. Radiological follow-up of transluminally inserted vascular endoprostheses: an experimental study using expanding spirals. Radiology. 1984 Sep;152(3):659-63. doi: 10.1148/radiology.152.3.6463245.

Balko A, Piasecki GJ, Shah DM, Carney WI, Hopkins RW, Jackson BT. Transfemoral placement of intraluminal polyurethane prosthesis for abdominal aortic aneurysm. J Surg Res. 1986 Apr;40(4):305-9. doi: 10.1016/0022-4804(86)90191-5.

Lawrence DD Jr, Charnsangavej C, Wright KC, Gianturco C, Wallace S. Percutaneous endovascular graft: experimental evaluation. Radiology. 1987 May;163(2):357-60. doi: 10.1148/radiology.163.2.2951767.

Palmaz JC, Sibbitt RR, Tio FO, Reuter SR, Peters JE, Garcia F. Expandable intraluminal vascular graft: a feasibility study. Surgery. 1986 Feb;99(2):199-205.

Palmaz JC, Parodi JC, Barone HD, et al. Transluminal bypass of experimental abdominal aortic aneurysm. RSNA 1990; 177(s):202.

Yoshioka T, Wright KC, Wallace S, Lawrence DD Jr, Gianturco C. Self-expanding endovascular graft: an experimental study in dogs. AJR Am J Roentgenol. 1988 Oct;151(4):673-6. doi: 10.2214/ajr.151.4.673.

Mirich D, Wright KC, Wallace S, Yoshioka T, Lawrence DD Jr, Charnsangavej C, Gianturco C. Percutaneously placed endovascular grafts for aortic aneurysms: feasibility study. Radiology. 1989 Mar;170(3 Pt 2):1033-7. doi: 10.1148/radiology.170.3.2916054.

Chuter TA, Green RM, Ouriel K, Fiore WM, DeWeese JA. Transfemoral endovascular aortic graft placement. J Vasc Surg. 1993 Aug;18(2):185-95; discussion 195-7. doi: 10.1067/mva.1993.42587.

Laborde JC, Parodi JC, Clem MF, Tio FO, Barone HD, Rivera FJ, Encarnacion CE, Palmaz JC. Intraluminal bypass of abdominal aortic aneurysm: feasibility study. Radiology. 1992 Jul;184(1):185-90. doi: 10.1148/radiology.184.1.1535160.

Hagen B, Harnoss BM, Trabhardt S, Ladeburg M, Fuhrmann H, Franck C. Self-expandable macroporous nitinol stents for transfemoral exclusion of aortic aneurysms in dogs: preliminary results. Cardiovasc Intervent Radiol. 1993 Nov-Dec;16(6):339-42. doi: 10.1007/BF02603137.

Parodi JC, Palmaz JC, Barone HD. Transfemoral intraluminal graft implantation for abdominal aortic aneurysms. Ann Vasc Surg. 1991 Nov;5(6):491-9. doi: 10.1007/BF02015271.

Parodi JC. Endovascular repair of abdominal aortic aneurysms. Advances in Vascular Surgery 1993; 1:85-106.

May J, White G, Waugh R, Yu W, Harris J. Transluminal placement of a prosthetic graft-stent device for treatment of subclavian artery aneurysm. J Vasc Surg. 1993 Dec;18(6):1056-9.

Cragg AH, Dake MD. Percutaneous femoropopliteal graft placement. Radiology. 1993 Jun;187(3):643-8. doi: 10.1148/radiology.187.3.8497609.

Dake MD, Miller DC, Semba CP, Mitchell RS, Walker PJ, Liddell RP. Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med. 1994 Dec 29;331(26):1729-34. doi: 10.1056/NEJM199412293312601.

Piquet P, Bartoli JM, Rolland PH, Mercier C. Tantalum Dacron co-knit stent for endovascular treatment of aorto-iliac aneurysms. Presented at the 17th World Congress of the International Union of Angiology, London, England, April 1995.

Parodi J. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Moore W. Presented the Southern California Chapter of the American College of Surgeons Meeting, Newport Beach, CA. January 1994.

Ahn R. Presented at VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

May J, White GH. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Chuter T. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Marin ML. Stented grafts for the treatment of aorto-iliac and femoropopliteal occlusive disease. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Vieth FJ, Mann ML, Panetta TF, Parodi JC, Cinaron J. Stented grafts for the treatment of traumatic arterial lesions and non-aortic aneurysms. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Semba CP, Dake MD, Mitchell RS, Miller DC. Endovascular grafting for the treatment of thoracic aortic aneurysms: Preliminary experience at Stanford University Medical Center. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Diethrich EB, Parazoglou CD, Lundquist P, Rodriguez-Lopez J, Lopez-Galarza L, Eckert J, Stone D, Cassess R, Matveevskii A. Early experience with aneurysm exclusion devices and endoluminal bypass prosthesis. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

Ivancev K, Chuter T, Lindblad B, et al. Endovascular treatment of perigraft perfusion following transfemoral aneurysm repair. World J Surg 1996; in press.

Chuter T, Hopinson B, Wendt G et al. Transfemoral aortic aneurysm repair with bifurcated endovascular grafts. Presented at the 43rd meeting of the International Society for Cardiovascular surgery, North American Chapter, New Orleans, LA June 1995.

Parodi JC. Endoluminal treatment of aortic aneurysms. Presented at the 2nd International Workshop on Interventional Radiology, Czech Radiological Society, Prague, June 1995.

Mailhe C. Results of the Stentor Trial. Presented at the 17th World Congress of the International Union of Angiology, London, England, April 1995.

Mann ML. Complications of endovascular stented grafts for the treatment of arterial lesions: The agony after ecstasy. Presented at the 43rd meeting of the International Society for Cardiovascular Surgery, North American Chapter, New Orleans, LA, June 1994.

Suggested standards for reports dealing with lower extremity ischemia. Prepared by the Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery/North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg. 1986 Jul;4(1):80-94. Erratum In: J Vasc Surg 1986 Oct;4(4):350.