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

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 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm

Resource links provided by NLM:

Genetics Home Reference related topics: familial thoracic aortic aneurysm and dissection

MedlinePlus related topics: Aneurysms Aortic Aneurysm

Genetic and Rare Diseases Information Center resources: Abdominal Aortic Aneurysm

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:	140
Study Start Date:	May 2005
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Interventional Endovascular Branched Stent-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).	Device: Endovascular Branched Stent-Graft 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


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

Criteria

Inclusion Criteria

Aortic aneurysms:
- greater than or equal to 6 cm in diameter in men,
- greater than or equal to 5.5 cm in diameter in women,
- and/or larger than 5 cm in diameter and enlarging at a rate of more than 5 mm/year,
- and/or iliac aneurysms larger than 4 cm in diameter.
Anticipated mortality comparable to published rates with conventional surgical treatment.
Life expectancy more than 2 years.
Ability to give informed consent.
Willingness to comply with follow-up schedule.
Suitable arterial anatomy for endovascular repair.

Exclusion Criteria

Free rupture of the aneurysm.
Pregnancy.
Known allergy to Nitinol, stainless steel, or polyester.
Unwillingness or inability to comply with the follow up schedule.
Serious systemic or groin infection.
Uncorrectable coagulopathy.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts


Contact: Linda M Reilly, MD	415 353 4366	linda.reilly@ucsfmedctr.org
Contact: Timothy AM Chuter, MD	415 353 4366	timothy.chuter@ucsfmedctr.org

Locations


United States, California
Division of Vascular Surgery, SFVAMC	Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Warren J Gaspar, MD
Principal Investigator: Timothy AM Chuter, MD
Principal Investigator: Linda M Reilly, MD
Sub-Investigator: Marlene Grenon, MD
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: Jade S Hiramoto, 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 ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1016/j.jvs.2008.11.102.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00483249 History of Changes
Other Study ID Numbers:	H5357-26067
Study First Received:	June 5, 2007
Last Updated:	October 1, 2014
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:


Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic	Aortic Diseases Cardiovascular Diseases Vascular Diseases

ClinicalTrials.gov processed this record on March 01, 2015