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

Status unconfirmed · Not applicable

Conditions studied: Descending Thoracic Aortic Disease

In brief

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.

Key facts

Study ID

NCT00546312

Run by

Arizona Heart Institute

People needed

332

Starts

2000-02-01

Expected to finish

2012-06-01

Last updated by the study team

2010-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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.

Where it is running

• Arizona Heart Institute — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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