Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases - Full Text View

Purpose

The purpose of this study is to evaluate the safety and efficacy of endovascular repair, using the Thoracic EXCLUDER Endoprosthesis, when used in the treatment of descending thoracic aortic disease as indicated by radiological testing at time of discharge, and 1, 6, 12 months and annually following implantation, and to determine the proportion of patients who experience adverse events during and after the implantation procedure, including disease-specific and overall mortality rates.

Condition	Intervention
Descending Thoracic Aortic Disease	Device: Thoracic EXCLUDER Endoprosthesis

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases

Further study details as provided by Arizona Heart Institute:

Primary Outcome Measures:

Technical success [ Time Frame: following procedure ] [ Designated as safety issue: Yes ]
Successful completion of the treatment at the initial time of the procedure defined by successful access to the arterial system, deployment, placement and patency of the Thoracic TAG Endoprosthesis at time of procedure.
Treatment Success [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Initial technical success and exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, defined as the absence of aneurysm enlargement (if aneurysm present) and avoidance of rupture, without major complications within 30 days of the procedure.
Clinical Success [ Time Frame: through 12 months ] [ Designated as safety issue: Yes ]
Treatment success followed by patency of the graft, and continued exclusion of the appropriate portion of the descending thoracic aortic disease from the blood circulation, without reintervention, rupture, and any major complications through twelve months.

Estimated Enrollment:	332
Study Start Date:	February 2000
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Stent-graft endoprosthesis is inserted by Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) 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:

Thoracic aortic disease deemed to warrant exclusion in order to prevent rupture or extension including dissection and transections.
Anatomy meets Thoracic EXCLUDER Endoprosthesis specification criteria.
Minimum 2 cm non-aneurysmal segment proximal and distal to the aneurysm.
- < 60 angle in the aortic arch may require additional length of non- aneurysmal segment if the arch is included in the treatment segment.
The patient is of a "high risk" status for surgical repair. The patient is characterized by the presence of co-morbid factors and/or thoracic aortic pathology that place the patient in a category of prohibitive risk for open repair, and, without intervention, and adverse event could be anticipated within days or weeks. The patient has an ASA score of IV or V.
Ability to comply with protocol requirements including follow-up.
Signed Informed Consent Form.

Exclusion Criteria:

> 4 mm aortic taper and inability to use devices of different diameters, to compensate for the taper, in the treatment area of the aorta.
Significant thrombus at the proximal or distal implantation sites.
Planned occlusion of the left carotid or celiac arteries, unless supplemental conduit provided.
Myocardial infarction within six weeks.
Degenerative connective tissue disease, e.g. Marfan's or Ehler Danlos Syndrome, unless the proximal and distal implantation sites of the Thoracic EXCLUDER Endoprosthesis are located within previously placed surgical grafts.
Female of child bearing potential with positive pregnancy test.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546312

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:

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.

Clouse WD, Hallett JW Jr, Schaff HV, Gayari MM, Ilstrup DM, Melton LJ 3rd. Improved prognosis of thoracic aortic aneurysms: a population-based study. JAMA. 1998 Dec 9;280(22):1926-9.

McNamara JJ, Pressler VM. Natural history of arteriosclerotic thoracic aortic aneurysms. Ann Thorac Surg. 1978 Nov;26(5):468-73.

Najafi H. 1993 Update. Ann Thorac Surg 1993; 55: 1042-5

von Segesser LK, Killer I, Jenni R, Lutz U, Turina MI. Improved distal circulatory support for repair of descending thoracic aortic aneurysms. Ann Thorac Surg. 1993 Dec;56(6):1373-80.

Hamerlijnck RP, Rutsaert RR, De Geest R, Brutel de la Riviere A, Defauw JJ, Vermeulen FE. Surgical correction of descending thoracic aortic aneurysms under simple aortic cross-clamping. J Vasc Surg. 1989 Apr;9(4):568-73.

Culliford AT, Ayvaliotis B, Shemin R, et al. Aneurysms of the descending aorta. J Thorac Cardiovasc Surg 1983; 85: 98-104

Carlson DE, Karp RB, Kouchoukos NT. Surgical treatment of aneurysms of the descending thoracic aorta: an analysis of 85 patients. Ann Thorac Surg. 1983 Jan;35(1):58-69.

Cooley DA, Baldwin RT. Technique of open distal anastomosis for repair of descending thoracic aortic aneurysms. Ann Thorac Surg. 1992 Nov;54(5):932-6.

Borst HG, Jurmann M, Buhner B, Laas J. Risk of replacement of descending aorta with a standardized left heart bypass technique. J Thorac Cardiovasc Surg. 1994 Jan;107(1):126-32; discussion 132-3.

Lawrie GM, Earle N, De Bakey ME. Evolution of surgical techniques for aneurysms of the descending thoracic aorta: twenty-nine years experience with 659 patients. J Card Surg. 1994 Nov;9(6):648-61.

Laschinger JC, Izumoto H, Kouchoukos NT. Evolving concepts in prevention of spinal cord injury during operations on the descending thoracic and thoracoabdominal aorta. Ann Thorac Surg. 1987 Dec;44(6):667-74. Review.

Rutherford RB; editor; Vascular Surgery, Fourth Edition; 1995, W. B. Saunders Co.

Fann JI, Miller, DC. Basic data underlying clinical decision making: Aortic dissection. Annals of vascular surgery 1995; 9:311-323

Torchiana DF, Shin RD, Akins CW, Hilgenberg AD, et. al. Delayed management of traumatic thoracic aortic disruption. Poster abstract presented at the 35th annual meeting of the Society of Thoracic Surgeons, San Antonio, Texas, January 1999

Kato M, Matsuda T, Kaneko M, Kuratani T, Mizushima T, Seo Y, Uchida H, Kichikawa K, Maeda M, Ohnishi K. Outcomes of stent-graft treatment of false lumen in aortic dissection. Circulation. 1998 Nov 10;98(19 Suppl):II305-11; discussion II311-2.

Sacks D, Marinelli DL, Martin LG, Spies JB. Reporting standards for clinical evaluation of new peripheral arterial revascularization devices. Technology Assessment Committee. J Vasc Interv Radiol. 1997 Jan-Feb;8(1 Pt 1):137-49. Review. No abstract available. Erratum in: J Vasc Interv Radiol 1997 Jul-Aug;8(4):658. J Vasc Interv Radiol 1997 May-Jun;8(3):492.

Responsible Party:	Edward B. Diethrich, MD, Arizona Heart Institute
ClinicalTrials.gov Identifier:	NCT00546312 History of Changes
Other Study ID Numbers:	G990299
Study First Received:	October 16, 2007
Last Updated:	May 25, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Aortic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases (Gore Thoracic)