• July 30, 2019

    Novel thoracic aorta device trials enrolling at Baylor Scott & White – The Heart Hospital Plano

Below are two novel thoracic aorta trials being conducted 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 second in enrollment nationally among 34 participating sites.

Inclusion Criteria:

  1. Presence of thoracic aortic pathology deemed to warrant surgical repair that requires proximal graft placement in Zone 0-2
  2. Age ≥18 years at time of informed consent signature
  3. Must have appropriate proximal aortic landing zone
  4. Must have appropriate target branch vessel landing zone

Exclusion Criteria:

  1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
  2. Previous endovascular repair of the ascending aorta
  3. Previous endovascular repair of the DTA with a non-Gore device
  4. Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access

Complete inclusion and exclusion criteria can be found here.

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.

Inclusion Criteria:

  1. Patient must have a type A thoracic aortic dissection and be considered a candidate for endovascular repair
  2. The proximal and distal landing zones for placement of graft should be at least 1 cm
  3. Distal landing zone must allow for continued perfusion of critical cerebral vessels
  4. The patient must be a high-risk surgical candidate according to the following established criteria: ASA score of IV

Exclusion Criteria:

  1. Pregnant or pediatric patients (younger than 21 years of age)
  2. Patients who have a condition that threatens to infect the stent graft/aortic valve prosthesis
  3. Patients with allergies to the stent graft material
  4. Patients with expected survival less than one year due to a condition other than the ascending aortic

Complete inclusion and exclusion criteria can be found here.

Principal Investigator: Dr. Brinkman
Study Contact: Megan White, 469.814.4181