Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal) - Full Text View

Purpose

The purpose of the study is to evaluate the TALENT endoluminal stent-graft system in patients with abdominal aortic aneurysms. The TALENT endoluminal stent-graft system is a flexible, implantable endoluminal vascular device preloaded in a placement system that is used to exclude abdominal aortic aneurysms.

Condition	Intervention
Abdominal Aortic Aneurysm	Device: TALENT Enhanced LPS Endoluminal Stent-Graft System

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Clinical Study of Abdominal Aortic Aneurysm Exclusion Using the TALENT Enhanced LPS Endoluminal Stent-Graft System

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Arizona Heart Institute:

Primary Outcome Measures:

Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency. [ Time Frame: At implant, time of discharge, and 1, 6, and 12 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the proportion of patients who experience adverse events. [ Time Frame: During and after implantation. ] [ Designated as safety issue: No ]
Determine the proportion of patients who experience comorbidities and overall mortality rates. [ Time Frame: During and after implantation. ] [ Designated as safety issue: No ]

Estimated Enrollment:	75
Study Start Date:	October 2002
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Device: TALENT Enhanced LPS Endoluminal Stent-Graft System roadmapping, and angiography for proper implant positioning. The TALENT endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

Arms

Assigned Interventions

Experimental: 1

Device: TALENT Enhanced LPS Endoluminal Stent-Graft System

roadmapping, and angiography for proper implant positioning. The TALENT endoluminal stent-graft endoprosthesis is inserted by delivery catheter and introducer sheath via a surgical cutdown (e.g., external iliac artery, femoral artery) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is ≥ 18 years of age.
Subject has a proximal AAA neck (distance between the top of the aneurysm and the renal arteries) ≥ 5 mm.
Subject has a proximal aortic neck diameter ≥ 14 mm and ≤ 32 mm.
Subject has an angle between the suprarenal aorta and the aneurysm ≤ 60°.
Subject has renal arteries ≥ 9 cm from the aortic neck bifurcation.
Subject has proximal and distal iliac neck diameters ≥ 8 mm and ≤ 24 mm.
Subject has a distal iliac neck length ≥ 15 mm.
Subject has signed the informed consent.
Subject will be available for follow-up at periodic intervals after the procedure.

Exclusion Criteria:

Subject has a document patent inferior mesenteric artery and an occluded or stenotic celiac and superior mesenteric artery.
Subject has a lesion that cannot be crossed with a guide wire.
Subject whose arterial access site cannot accommodate the delivery catheter.
Subject has no distal vascular bed.
Subject has systemic infection, or is suspected of having systemic infection.
Subject has an untreatable bleeding diathesis.
Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549432

Locations

United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006

Sponsors and Collaborators

Arizona Heart Institute

Investigators

Principal Investigator:

Edward B Diethrich, M.D.

Arizona Heart Institute

More Information

Publications:

Becker GJ, Benenati JF, Zemel G, Sallee DS, Suarez CA, Roeren TK, Katzen BT. Percutaneous placement of a balloon-expandable intraluminal graft for life-threatening subclavian arterial hemorrhage. J Vasc Interv Radiol. 1991 May;2(2):225-9.

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.

Blum U, Langer M, Spillner G, Mialhe C, Beyersdorf F, Buitrago-Tellez C, Voshage G, Duber C, Schlosser V, Cragg AH. Abdominal aortic aneurysms: preliminary technical and clinical results with transfemoral placement of endovascular self-expanding stent-grafts. Radiology. 1996 Jan;198(1):25-31.

Collin J, Araujo L, Walton J, Lindsell D. Oxford screening programme for abdominal aortic aneurysm in men aged 65 to 74 years. Lancet. 1988 Sep 10;2(8611):613-5.

Cronenwett JL and LN Samspon. 1995. Aneurysms of the abdominal aorta and iliac arteris. In Current Diagnosis and Treatment in Vascular Surgery, 1st edition, RH Dean, JST Yao and DC Brewster, eds. Appleton and Lange, Norwalk, CT. pp 220-238.

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.

DUBOST C, ALLARY M, OECONOMOS N. Resection of an aneurysm of the abdominal aorta: reestablishment of the continuity by a preserved human arterial graft, with result after five months. AMA Arch Surg. 1952 Mar;64(3):405-8. No abstract available.

Geroulakos G, Nicolaides A. Infrarenal abdominal aortic aneurysms less than five centimetres in diameter: the surgeon's dilemma. Eur J Vasc Surg. 1992 Nov;6(6):616-22. Review.

Gloviczki P. Ruptured abdominal aortic aneurysms. In Vascular Surgery, 4th edition, Rutherford, RB, ed. Saunders, Philadelphia, PA, chapter 76.

Hallett JW Jr, Bower TC, Cherry KJ, Gloviczki P, Joyce JW, Pairolero PC. Selection and preparation of high-risk patients for repair of abdominal aortic aneurysms. Mayo Clin Proc. 1994 Aug;69(8):763-8. Review.

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.

Johansson G, Swedenborg J. Ruptured abdominal aortic aneurysms: a study of incidence and mortality. Br J Surg. 1986 Feb;73(2):101-3.

Johansen K. Ruptured abdominal aortic aneurysm: how should recent outcome studies impact current practices? Semin Vasc Surg. 1995 Jun;8(2):163-7. Review. No abstract available.

Johnston KW. Nonruptured abdominal aortic aneurysm: six-year follow-up results from the multicenter prospective Canadian aneurysm study. Canadian Society for Vascular Surgery Aneurysm Study Group. J Vasc Surg. 1994 Aug;20(2):163-70.

Lee JT, Lee J, Aziz I, Donayre CE, Walot I, Kopchok GE, Heilbron M Jr, Lippmann M, White RA. Stent-graft migration following endovascular repair of aneurysms with large proximal necks: anatomical risk factors and long-term sequelae. J Endovasc Ther. 2002 Oct;9(5):652-64.

Melton LJ 3rd, Bickerstaff LK, Hollier LH, Van Peenen HJ, Lie JT, Pairolero PC, Cherry KJ, O'Fallon WM. Changing incidence of abdominal aortic aneurysms: a population-based study. Am J Epidemiol. 1984 Sep;120(3):379-86.

Nehler MR, Taylor LM Jr, Moneta GL, Porter JM. Indications for operation for infrarenal abdominal aortic aneurysms: current guidelines. Semin Vasc Surg. 1995 Jun;8(2):108-14. Review. No abstract available.

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.

O'Donnell TF, Darling RC, Linton RR. Is 80 years too old for aneurysmectomy? Arch Surg. 1976 Nov;111(11):1250-7.

O'Hara PJ, Hertzer NR, Krajewski LP, Tan M, Xiong X, Beven EG. Ten-year experience with abdominal aortic aneurysm repair in octogenarians: early results and late outcome. J Vasc Surg. 1995 May;21(5):830-7; discussion 837-8.

Pairolero PC. Repair of abdominal aortic aneurysms in high-risk patients. Surg Clin North Am. 1989 Aug;69(4):755-63.

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

Perler BA. 1995. Natural history of abdominal aortic aneurysm. A clinical presentation. Seventh Annual International Symposium on Vascular Diagnosis and Intervention. pp. 173-175.

Rose WW and CB Ernst. 1995. Abdominal aortic aneurysm. Comprehensive Ther, 21 (7):339-343.

Scott RA, Ashton HA, Kay DN. Abdominal aortic aneurysm in 4237 screened patients: prevalence, development and management over 6 years. Br J Surg. 1991 Sep;78(9):1122-5.

Veith FJ, Abbott WM, Yao JS, Goldstone J, White RA, Abel D, Dake MD, Ernest CB, Fogarty TJ, Johnston KW, et al. Guidelines for development and use of transluminally placed endovascular prosthetic grafts in the arterial system. Endovascular Graft Committee. J Vasc Surg. 1995 Apr;21(4):670-85. No abstract available.

Zarins CK, Harris EJ Jr. Operative repair for aortic aneurysms: the gold standard. J Endovasc Surg. 1997 Aug;4(3):232-41. Review.

Responsible Party:	Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier:	NCT00549432 History of Changes
Other Study ID Numbers:	G020149
Study First Received:	October 24, 2007
Last Updated:	May 14, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 23, 2013