NCT00549432

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

10 years

First QC Date

October 24, 2007

Last Update Submit

May 14, 2009

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency.

    At implant, time of discharge, and 1, 6, and 12 months.

Secondary Outcomes (2)

  • Determine the proportion of patients who experience adverse events.

    During and after implantation.

  • Determine the proportion of patients who experience comorbidities and overall mortality rates.

    During and after implantation.

Study Arms (1)

1

EXPERIMENTAL
Device: TALENT Enhanced LPS Endoluminal Stent-Graft System

Interventions

TALENT Enhanced LPS Endoluminal Stent-Graft SystemDEVICE

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Related Publications (28)

  • 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. doi: 10.1016/s1051-0443(91)72286-0.

    PMID: 1799760BACKGROUND

  • 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.

    PMID: 6481873BACKGROUND

  • 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. doi: 10.1148/radiology.198.1.8539389.

    PMID: 8539389BACKGROUND

  • Pathology of nonspecific abdominal aortic aneurysm disease. In Current Therapy in Vascular Surgery, 2nd edition, CB Ernst and JC Stanley, eds. B.C. Decker, Philadelphia, PA.

    BACKGROUND

  • 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. doi: 10.1016/s0140-6736(88)90649-6.

    PMID: 2900988BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 7984192BACKGROUND

  • 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.

    PMID: 14894065BACKGROUND

  • 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. doi: 10.1016/s0950-821x(05)80838-2.

    PMID: 1451817BACKGROUND

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

    BACKGROUND

  • 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. doi: 10.1016/s0025-6196(12)61096-9.

    PMID: 8035633BACKGROUND

  • 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.

    PMID: 3730787BACKGROUND

  • Johansson G, Swedenborg J. Ruptured abdominal aortic aneurysms: a study of incidence and mortality. Br J Surg. 1986 Feb;73(2):101-3. doi: 10.1002/bjs.1800730205.

    PMID: 3947894BACKGROUND

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

    PMID: 7670667BACKGROUND

  • 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. doi: 10.1016/0741-5214(94)90002-7.

    PMID: 8040938BACKGROUND

  • 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. doi: 10.1177/152660280200900517.

    PMID: 12431151BACKGROUND

  • 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. doi: 10.1093/oxfordjournals.aje.a113902.

    PMID: 6475915BACKGROUND

  • 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. No abstract available.

    PMID: 7670661BACKGROUND

  • 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.

    PMID: 2674715BACKGROUND

  • O'Donnell TF, Darling RC, Linton RR. Is 80 years too old for aneurysmectomy? Arch Surg. 1976 Nov;111(11):1250-7. doi: 10.1001/archsurg.1976.01360290084012.

    PMID: 985073BACKGROUND

  • 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. doi: 10.1016/s0741-5214(05)80015-1.

    PMID: 7769742BACKGROUND

  • Pairolero PC. Repair of abdominal aortic aneurysms in high-risk patients. Surg Clin North Am. 1989 Aug;69(4):755-63. doi: 10.1016/s0039-6109(16)44882-6.

    PMID: 2749441BACKGROUND

  • 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.

    PMID: 1837729BACKGROUND

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

    BACKGROUND

  • Rose WM 3rd, Ernst CB. Abdominal aortic aneurysm. Compr Ther. 1995 Jul;21(7):339-43. No abstract available.

    PMID: 7554809BACKGROUND

  • 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. doi: 10.1002/bjs.1800780929.

    PMID: 1933203BACKGROUND

  • 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. doi: 10.1016/s0741-5214(95)70198-2. No abstract available.

    PMID: 7707571BACKGROUND

  • Zarins CK, Harris EJ Jr. Operative repair for aortic aneurysms: the gold standard. J Endovasc Surg. 1997 Aug;4(3):232-41. doi: 10.1583/1074-6218(1997)0042.0.CO;2.

    PMID: 9291048BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Edward B Diethrich, M.D.

    Arizona Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

October 1, 2002

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

US(1)