Clinical Trials at the Aortic Program

The Aortic Program is involved in a series of device clinical trials, offering some of the latest medical advances to our patients. Trials are typically available for certain patients with diseases such as aortic aneurysm and/or dissection, traumatic aortic transections, and others.

STABLE II Zenith Dissection Clinical Study (Cook Medical)
Principle Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 28600
Contact: Laura Sarmiento: (310) 423-4295
Status: Enrolling
Summary:
This clinical investigation will include any patient with an acute, complicated, type B aortic dissection. The patients will be treated with the Cook Zenith TX2 Dissection Endovascular Graft. A thoracic dissection is a tear in the wall of the aorta that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

IRAD (International Registry for Aortic Dissection)
Principle Site Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 28384
Contact: Johnny Thomas (310) 423-4614
Status: Enrolling
Summary:
The International Registry of Acute Aortic Dissections is a consortium of research centers that are evaluating the current management and outcomes of acute aortic dissection. It was established in 1996, and currently has 30 large referral centers in 11 countries participating in the registry. The main purpose of IRAD is to assess the etiological factors, modes of presentation, clinical features, treatment, and hospital outcomes of patients with aortic dissection around the world.

AVE/Talent Endoluminal Stent-Graft System for the Treatment of Thoracic Aortic Lesions (Medtronic)
Institutional Single Investigator Investigational Device Exemption # G010356;
Co-Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 10356
Contact: Abeline LoBue (310) 222-5249
Status: Enrolling
Summary:
In this Single Institutional Single Investigator Investigational Device Exemption trial, the application and outcome of the Medtronic stent graft system is evaluated in various aortic pathologies.

Dissection Valiant trial (Medtronic Endovascular)
Principle Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 23873
Contact: Laura Sarmiento: (310) 423-4295
Status: Enrollment completed, follow-up for five years.
Summary:
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

TRANSFIX Zenith® Transection Clinical Study (Cook Endovascular)
Principle Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 30915
Contact: Laura Sarmiento: (310) 423-4295
Status: Enrolling
Summary: The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury. The patients with blunt aortic transection are enrolled in this trial, who are treated by endovascular means using the Valiant Thoracic stent graft. They are followed for up to five years after the index operation with physical exam, CT scans, laboratory work and chest x-rays. The goal is to evaluate the mid-term outcome of this patient population, and to investigate any device-specific complications.

Talent descending thoracic aortic aneurysm endovascular repair post-approval study (THRIVE Trial)
Principle Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 23853
Contact: Laura Sarmiento: (310) 423-4295
Status: Enrolling
Summary: The THRIVE trial is a post-marketing-approval study for Medtronic Talent stent graft. The patients with thoracic aortic aneurysm and penetrating aortic ulcer are enrolled in this trial, who are treated by endovascular means using the Talent Thoracic stent graft. They are followed for up to five years after the index operation with physical exam, CT scans, laboratory work and chest x-rays. The goal is to evaluate the mid-term outcome of this patient population, and to investigate any device-specific complications.

Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Co-Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 35249
Contact: Abeline LoBue (310) 222-5249
Status: enrollment completed, follow-up for five years.
Summary:
The primary objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute complicated type B aortic dissection. A thoracic dissection is a tear in the wall of the aorta that causes blood to flow between the layers of the aorta and force the layers apart (dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

Medtronic Valiant stent graft for aortic transection (RESCUE Trial)
Principle Investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 25260
Contact: Laura Sarmiento: (310) 423-4295
Status: Enrollment completed, follow-up for five years.
Summary:
The RESCUE trial is a phase III trial for Medtronic Valiant stent graft. The patients with blunt aortic transection are enrolled in this trial, who are treated by endovascular means using the Valiant Thoracic stent graft. They are followed for up to five years after the index operation with physical exam, CT scans, laboratory work and chest x-rays. The goal is to evaluate the mid-term outcome of this patient population, and to investigate any device-specific complications.

Genetic determinants trial
Principal Investigator: Robert Siegel, MD, Co-investigator: Ali Khoynezhad, MD, PhD
IRB Approval Number: 4120
Contact: (310) 423-3838
Status: Enrolling
Summary:
The present study is designed to assess familial clustering of Bicuspid Aortic Valve disease (BAV) and to identify genes that may be involved in the development of BAV and its complications.  The study enrolls subjects with age of 5 years or older with bicuspid aortic valve disease and their first-degree family members.  All subjects will have an ultrasound to evaluate for BAV, blood draws for genetic studies and serum markers and hand-forearm X-ray.  In addition, a medical and family history questionnaire will be filled out and a family tree be constructed.  Subjects will be followed for 5 years.