Clinical Trial: Clinical Study of Thoracic Aortic Aneurysm Exclusion
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Clinical Study of Thoracic Aortic Aneurysm Exclusion Using the VALIANT System
Brief Summary: The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal device preloaded in a delivery system that is used to exclude thoracic aortic lesions (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and both traumatic and degenerative pseudoaneurysms.
Detailed Summary:
A vascular aneurysm is a permanent, localized dilatation of a blood vessel at least 1 1/2 to 2 times the normal vessel diameter. The aorta is the most frequent site for aneurysms, with approximately 10% of aortic aneurysms located above the renal arteries in the thoracic segment. Thoracic aortic aneurysms (TAAs) are less common than abdominal aorta, however, detection of TAAs is increasing, perhaps due to an aging population, increased diagnostic capability or an increase in prevalence.
Untreated thoracic aneurysms can be life-threatening. As many as 78% of untreated patients with TAA die within 5 years after diagnosis, most often from rupture of the aneurysm. Conventional surgical treatment, either tube graft placement or patch aortoplasty, is a high risk surgical procedure. Repair of the thoracic descending aorta is performed with a thoracotomy and cross-clamping of the aorta, with or without a shunt by-pass to maintain distal perfusion.
As an alternative to conventional surgery, a less invasive endovascular procedure has been developed that may be used to treat certain aneurysms. A collapsed stent-graft, a metal stent coupled with a fabric graft, is introduced into the vasculature, advanced to the size of the aneurysm, and deployed to span the aneurysm. The device creates a new aortic lumen, excluding the aneurysm sac from blood flow while maintaining flow within the stent-graft. This less invasive technique is designed to prevent or decrease the need for open surgery, to reduce the need for blood transfusion, to decrease the use of anesthetics and other drugs, and to speed recovery time. A reduction in intensive care and total hospital stay should result, leading to an increase quality of life following the procedure and a reduction in cost.
The primary objective of thi
Sponsor: Arizona Heart Institute
Current Primary Outcome: Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency. [ Time Frame: At implant, time of discharge, and 1, 6, and 12 months. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Determine the proportion of patients who experience adverse events. [ Time Frame: During and after implantation. ]
- Determine the proportion of patients who experience comorbidities and overall mortality rates. [ Time Frame: During and after implantation. ]
Original Secondary Outcome: Same as current
Information By: Arizona Heart Institute
Dates:
Date Received: October 24, 2007
Date Started: October 2002
Date Completion: September 2012
Last Updated: May 14, 2009
Last Verified: May 2009
