Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases

NCT00546312 | Unknown

• 1 other identifier: G990299
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Descending Thoracic Aortic Disease

Outcome Measures

Primary Outcomes (3)

• Technical success

  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.

  following procedure

• Treatment Success

  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.

  30 days

• Clinical Success

  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.

  through 12 months

Interventions

Thoracic EXCLUDER Endoprosthesis DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Arizona Heart Institute: lead

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Related Publications (21)

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• Fann JI, Mitchell RS, Dake DC, Miller DC. Results of endovascular stent-grafting in patients with thoracic aortic aneurysm. Progress in Vascular Surgery chapter 19

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• 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.

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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 16, 2007
• First Posted: October 18, 2007
• Study Start: February 1, 2000
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 27, 2010

Record last verified: 2009-05

Locations

US (1)