Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00483249

Purpose

This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.

Condition	Intervention	Phase
Thoracoabdominal Aortic Aneurysm Paravisceral Abdominal Aortic Aneurysm	Device: Endovascular Branched Stent-Graft	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm Surgery

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Successful implantation of TAAA branched stent-graft. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Long term success of TAAA branched stent-graft treatment. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	May 2005
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Industry manufactured branched stent-graft for treatment of TAAA/PVAAA.

Detailed Description:

A TAAA or PVAAA is an abnormal enlargement of the aorta, the main artery in the chest and abdomen. The standard operation for TAAA of PVAAA is performed through a long incision extending down the side of the chest and the front of the abdomen. In the standard operation, the weak area of the aorta is replaced with a fabric sleeve (graft). The investigational operation is done making small incisions in both groins and the right arm and placing a graft in the aorta through tubes that are inserted through the femoral and brachial arteries, than fastening it in position with metal springs(stents). The combination of a stent and a graft is known as a stent-graft. Compared with standard operation, the potential advantages of endovascular TAAA/PVAAA repair include less pain, less disturbance of intestinal function, a lower risk of pulmonary or cardiac complications and shorter hospital stay. The main disadvantage of endovascular TAAA/PVAAA is an unknown success rate.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Aneurysm >6cm in diameter or >5cm in diameter which is enlarging at a rate of >10mm/year
Anticipated mortality > 20% with conventional surgical treatment
Life expectancy > 2 years
Absence of a dominant artery to the spinal cord arising from the are of stent-graft implantation
Ability to give informed consent and willingness to comply with follow-up schedule
Suitable arterial anatomy for endovascular repair

Exclusion Criteria:

Free rupture of the aneurysm
Pregnancy
Anaphylactic reaction to contrast material
Allergy to stainless steel or polyester
Unwillingness or inability to comply with the follow up schedule
Serious systemic or groin infection
Uncorrectable coagulopathy
Inability to give informed consent in English

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483249

Contacts

Contact: Timothy AM Chuter, MD	415 353 4366	chutert@surgery.ucsf.edu
Contact: Linda M Reilly, MD	415 353 4366	reillyl@surgery.ucsf.edu

Locations

United States, California
Division of Vascular Surgery, UCSF	Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Timothy AM Chuter, MD
Principal Investigator: Linda M Reilly, MD
Sub-Investigator: Darren B Schneider, MD
Sub-Investigator: Jade S Hiramoto, MD
Division of Vascular Surgery, SFVAMC	Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Joseph H Rapp, MD
Principal Investigator: Timothy AM Chuter, MD
Principal Investigator: Linda M Reilly, MD

Sponsors and Collaborators

University of California, San Francisco

More Information

Publications:

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

Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.

Martin GH, O'Hara PJ, Hertzer NR, Mascha EJ, Krajewski LP, Beven EG, Clair DG, Ouriel K. Surgical repair of aneurysms involving the suprarenal, visceral, and lower thoracic aortic segments: early results and late outcome. J Vasc Surg. 2000 May;31(5):851-62.

Cambria RP, Davison JK, Carter C, Brewster DC, Chang Y, Clark KA, Atamian S. Epidural cooling for spinal cord protection during thoracoabdominal aneurysm repair: A five-year experience. J Vasc Surg. 2000 Jun;31(6):1093-102.

Walker SR, Yusuf SW, Wenham PW, Hopkinson BR. Renal complications following endovascular repair of abdominal aortic aneurysms. J Endovasc Surg. 1998 Nov;5(4):318-22.

Thompson JP, Boyle JR, Thompson MM, Strupish J, Bell PR, Smith G. Cardiovascular and catecholamine responses during endovascular and conventional abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg. 1999 Apr;17(4):326-33.

Zarins CK, White RA, Schwarten D, Kinney E, Diethrich EB, Hodgson KJ, Fogarty TJ. AneuRx stent graft versus open surgical repair of abdominal aortic aneurysms: multicenter prospective clinical trial. J Vasc Surg. 1999 Feb;29(2):292-305; discussion 306-8.

May J, White GH, Yu W, Ly CN, Waugh R, Stephen MS, Arulchelvam M, Harris JP. Concurrent comparison of endoluminal versus open repair in the treatment of abdominal aortic aneurysms: analysis of 303 patients by life table method. J Vasc Surg. 1998 Feb;27(2):213-20; discussion 220-1.

Chuter TA, Reilly LM, Faruqi RM, Kerlan RB, Sawhney R, Canto CJ, LaBerge JM, Wilson MW, Gordon RL, Wall SD, Rapp J, Messina LM. Endovascular aneurysm repair in high-risk patients. J Vasc Surg. 2000 Jan;31(1 Pt 1):122-33.

Mitchell RS, Miller DC, Dake MD, Semba CP, Moore KA, Sakai T. Thoracic aortic aneurysm repair with an endovascular stent graft: the "first generation". Ann Thorac Surg. 1999 Jun;67(6):1971-4; discussion 1979-80.

Kinney EV, Kaebnick HW, Mitchell RA, Jung MT. Repair of mycotic paravisceral aneurysm with a fenestrated stent-graft. J Endovasc Ther. 2000 Jun;7(3):192-7.

Iwase T, Inoue K, Sato M, Yoshida Y, Ueno K, Tanaka H, Tamaki S. Transluminal repair of an infrarenal aortoiliac aneurysm by a combination of bifurcated and branched stent grafts. Catheter Cardiovasc Interv. 1999 Aug;47(4):491-4.

Chuter TA, Gordon RL, Reilly LM, Goodman JD, Messina LM. An endovascular system for thoracoabdominal aortic aneurysm repair. J Endovasc Ther. 2001 Feb;8(1):25-33.

Anderson JL, Berce M, Hartley DE. Endoluminal aortic grafting with renal and superior mesenteric artery incorporation by graft fenestration. J Endovasc Ther. 2001 Feb;8(1):3-15.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Chang CK, Chuter TA, Niemann CU, Shlipak MG, Cohen MJ, Reilly LM, Hiramoto JS. Systemic inflammation, coagulopathy, and acute renal insufficiency following endovascular thoracoabdominal aortic aneurysm repair. J Vasc Surg. 2009 May;49(5):1140-6.

Responsible Party:	UCSF ( Linda M. Reilly, MD )
Study ID Numbers:	H5357-26067
Study First Received:	June 5, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00483249 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

Thoracoabdominal
Paravisceral
Aneurysm
Endovascular
Stent-Graft

Additional relevant MeSH terms:

Aortic Diseases
Aortic Aneurysm, Thoracic
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on February 08, 2010