Below are two novel trials exploring conditions of the aorta that are currently enrolling at Baylor Scott & White – The Heart Hospital Plano. These trials leverage our multi-disciplinary team approach, which brings Cardiothoracic and Vascular surgeons together in our TAA clinic for collaborative, simultaneous visits with each patient. This approach has proven time and again to better inform decisions surrounding patient care plans and help produce stronger outcomes.
Evaluation of the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
The purpose of this study is to determine whether the Gore TAG Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta. Baylor Scott & White – The Heart Hospital Plano is the only site in North Texas participating in the trial and is currently ranked 2nd in enrollment nationally among 34 participating sites.
- Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2
- Age ≥18 years at time of informed consent signature
- Must have appropriate proximal aortic landing zone
- Must have appropriate target branch vessel landing zone
- Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- Previous endovascular repair of the ascending aorta
- Previous endovascular repair of the DTA with a non-Gore device
- Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
Proposed Single Center Investigational Device Exemption Feasibility of Endovascular Repair of Ascending Aortic Dissections
The purpose of this investigator-initiated early feasibility study is to investigate the outcome of selected patients with ascending aortic pathologies, including Type A aortic dissection and retrograde Type A aortic dissection, receiving endovascular repair with the Valiant PS-IDE Stent Graft device. The investigators propose to study patients with dissections affecting the aorta between the sinus of valsalva and the innominate artery orifice (with no involvement of aortic valve). In these patients, the ascending aorta will be repaired using the stent graft.
- Patient must have a type A thoracic aortic dissection and be considered a candidate for endovascular repair
- The proximal and distal landing zones for placement of graft should be at least 1 cm
- Distal landing zone must allow for continued perfusion of critical cerebral vessels
- The patient must be a high-risk surgical candidate according to the following established criteria: ASA score of IV
- Pregnant or pediatric patients (younger than 21 years of age)
- Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis
- Patients with allergies to the stent graft material
- Patients with expected survival less than one year due to a condition other than the ascending aortic