Clinical Trial: Clinical Study of Thoracic Excluder Endoprosthesis to Treat Descending Thoracic Aortic Diseases
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Clinical Study Evaluating Use of the Thoracic EXCLUDER Endoprosthesis in the Treatment of Descending Thoracic Aortic Diseases
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.
Detailed Summary:
Thoracic aortic aneurysm, while relatively rare, is a potentially lethal disorder with a poor long-term prognosis if not treated. As the aortic diameter increases, wall tension becomes higher, leading to further expansion of the aneurysm. Consequently, this disease process is a "progressive and self propagating" phenomena, and the natural history of the disease is progressive expansion of the aneurysm with eventual rupture. Patients with descending thoracic aortic aneurysms frequently have concomitant major medical conditions, making them poor candidates for major surgical procedures. Concomitant conditions may include: hypertension, chronic obstructive pulmonary disease, congestive heart failure, and peripheral vascular disease, including abdominal aortic aneurysm, previous stroke and peripheral arterial occlusive disease.
The accepted treatment for aneurysms deemed to warrant intervention is surgical resection and repair. Operative and post operative complications contributing to early mortality after surgical repair of descending thoracic aortic aneurysms include low cardiac output, pulmonary insufficiency, myocardial infarction, postoperative hemorrhage, pulmonary embolism and sepsis.
In addition to mortality, two of the gravest complications of this surgical procedure, neurologic complications due to spinal cord ischemia, such as paraplegia and paraparesis, and renal failure or dysfunction, remain common.
Dissections, another disease process of the descending thoracic aorta, are rare. Aortic dissections are thought to start with a tear or disruption of the intimal lining of the aorta, either due to medial degenerative diseases, trauma or rupture of an ulcerated intimal plaque. Blood at systemic arterial pressures invades the underlying medial layer of the aor
Sponsor: Arizona Heart Institute
Current Primary Outcome:
- Technical success [ Time Frame: following procedure ]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 ]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 ]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.
Original Primary Outcome: Technical, Treatment and Clinical Success [ Time Frame: 1 month, 6 month, 12 months, and annually to 60 months ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Arizona Heart Institute
Dates:
Date Received: October 16, 2007
Date Started: February 2000
Date Completion: June 2012
Last Updated: May 25, 2010
Last Verified: May 2009
