Enrolment has begun in two separate clinical trials studying the use of the Valiant Thoracic Stent Graft System (Medtronic) for treating descending thoracic aortic aneurysms and descending thoracic aortic dissections, respectively. The Valiant device is the company’s next-generation thoracic endograft designed for minimally-invasive treatment of potentially fatal thoracic aortic conditions.
The VALOR II clinical trial, which will enroll a maximum of 125 patients at up to 30 investigational sites in the US, will examine the safety and efficacy of Valiant in treating descending thoracic aortic aneurysms. It is anticipated that data from this trial will be used to support application to the FDA for product approval. The national principal investigator for VALOR II is Dr Ronald Fairman from the University of Pennsylvania.
“The Valiant stent graft has quickly become the most widely used thoracic graft outside the United States because it offers precision deployment and expanded sizing options that allow surgeons to treat a large array of patient anatomies,” said Fairman, Chief of the Division of Vascular Surgery, University of Pennsylvania Health System. “We are thrilled to have initiated the VALOR II clinical trial in the US, as we believe it will advance and refine endovascular therapy in the thoracic aorta.” Dr Joseph Bavaria, site principal investigator at the University, enrolled the first patient in December 2006.
The VIRTUE registry will enroll 100 patients at approximately 20 clinical centres in Western Europe and will evaluate the use of the Valiant graft for the treatment of descending thoracic aortic dissections (type B dissections). The objective of the VIRTUE registry is to collect additional health economic and clinical performance data on Valiant for the treatment of acute dissections, complicated or expanding sub-acute dissections and expanding chronic dissections.
The principal investigator for the VIRTUE registry is Professor Matt Thompson, St George’s Hospital, University of London, UK. “Descending aortic dissection is a potentially fatal condition, and traditional treatment with open surgery or medical management can result in high morbidity and mortality,” said Thompson. “The early use of stent graft therapy in both elective and emergency treatments of type B dissections has produced very encouraging outcomes, but we need to learn more about the effectiveness of this therapy. Our goal is to offer patients the best treatment option possible, and the VIRTUE study may help us better understand when to use thoracic endograft therapy in the reconstruction of an aortic dissection.” Dr Ivan Degrieck, Onze Lieve Vrouw Hospital in Aalst, Belgium, implanted the first patient in the VIRTUE study.
The Valiant Stent Graft has been available outside the US since 2005 for the treatment of thoracic aortic aneurysms, dissections and other lesions.