Aortic Clinical Trials

Cedars-Sinai Heart Institute is currently conducting the following Aortic trials:

Talent descending thoracic aortic aneurysm endovascular repair post-approval study (THRIVE Trial)

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 23873
Contact: Anila Saeed: 424315-4431
Status: Follow-up

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.

 


 

Medtronic Valiant stent graft for complicated acute type B aortic dissection (DISSECTION)

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 23873
Contact: Anila Saeed: 424-315-4431
Status: Follow-up

Summary:
The Valiant dissection study is a phase III stent graft trial. The patients with complicated acute type B aortic dissection 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.

 


 

Use of the Zenith® Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissection (STABLE II)

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 23873
Contact: Anila Saeed: 424-315-4431
Status: Enrolling

Summary:
The STABLE II dissection study is a phase III stent graft trial. Any patient with an acute, complicated, type B aortic dissection with either aortic rupture or branch vessel obstruction/compromise that results in malperfusion is eligible for enrollment in the study. 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 safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with complicated, type B aortic dissection.

 


 

A Prospective, Randomized Study to Compare Progel® Vascular Sealant to Gelfoam® Plus as an Adjunct for the Control of Bleeding in Subjects Undergoing Thoracic Aortic Surgery; NEO13-100

National Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 32997
Contact: Anila Saeed: 424-315-4431
Status: Enrolling

Summary:
This study is a phase III device trial. Patients who are scheduled for non-emergent, thoracic surgery involving the aortic valve, ascending aorta, or aortic arch on cardiopulmonary bypass will be assessed for potential study eligibility. They are followed for up to 1 month after the index operation with physical exam and  laboratory work. The goal is to compare the time to hemostasis at the aortic anastomotic suture line in subjects receiving Progel® (Test group) to that in subjects receiving Gelfoam® Plus (Control group) on anastomotic suture lines involving the aortic valve, ascending aorta, or aortic arch while on cardiopulmonary bypass.

 


 

Medtronic Valiant thoracic stent-graft for aortic transection. RESCUE trial

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 25260
Contact: Anila Saeed: 424-315-4431
Status: Follow-up

Summary:
The RESCUE transection study is a phase III stent graft trial. Any patient with an acute, traumatic aortic transection due to blunt injury is eligible for enrollment in the study. 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 safety and effectiveness of the Valiant Endovascular System in the treatment of patients with aortic transection.

 


 

A Phase II, Randomized, Placebo-Controlled, Double-Blind (Sponsor Open) Study of GSK1278863, a HIF-Prolyl Hydroxylase Inhibitor, to Reduce Ischemic Events in Patients Undergoing Thoracic Aortic Aneurysm Repair (DEPHINES)

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 32595
Contact: Anila Saeed: 424-315-4431
Status: Enrolling

Summary:
The DEPHINES study is a phase II study of GSK1278863 in patients undergoing thoracic aortic aneurysm repair. The patients with descending thoracic aorta , thoracoabdominal aortic aneurysms or chronic dissections may be enrolled in this trial.  They may be treated by endovascular means (TEVAR) or an open surgery. They are followed for 30 days after the index operation with physical exam, laboratory work and neurological assessments. The goal is to assess the effect of prophylactic GSK1278863 versus placebo on cerebral spinal fluid (CSF) of CNS injury.

 


 

AtriCure Synergy Ablation Lesions for Non-Paroxysmal Forms of Atrial Fibrillation Treatment during Concomitant On-Pump Endo//Epicardial Cardiac Surgery; CP2011-1 (ABLATE-PAS)

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 31258
Contact: Anila Saeed: 424-315-4431
Status: Enrolling

Summary:
The ABLATE-PAS study is a post-marketing trial. This prospective, open label, multi-center, observational, single arm registry is designed to monitor the AtriCure Synergy Ablation System continued safety and efficacy during the peri-procedural and long term phase during commercial use in patients being treated for non-paroxysmal forms of atrial fibrillation who are undergoing a concomitant open, on-pump cardiac surgical procedure.  They are followed for up to three years after the index operation with physical exam, rhythm assessment (12-lead ECG, device interrogation or holter monitor) and laboratory work. The primary goal is to evaluate clinical outcomes in patients treated during commercial use of the AtriCure Synergy Ablation System by physicians performing the Maze IV procedure.

 


 

Sorin Freedom Solo aortic valve bioprosthesis

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 27888
Contact: Anila Saeed: 424-315-4431
Status: Follow-up

Summary:
The Freedom Solo is a novel valve technology for patients with aortic valve stenosis. The goal of this national study is to establish the safety and outcomes of this platform. The patients will be followed up on yearly intervals for five years.

 


 

Single Center Investigator-Initiated Investigational Device Exemption: Feasibility of Endovascular Repair of Ascending Aortic Pathologies using Medtronic Valiant Stent Graft System

National Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 20766-01
Contact: Anila Saeed: 424-315-4431
Status: Enrolling

Summary:
This is the first FRA-approved study in the United States to treat various ascending aortic pathologies using a less-invasive stent graft technology. The goal of the study is to document the safety of the stent grafting in the ascending thoracic aorta. The patients are followed up to five years.

 


 

Cook thoracic stent-graft for traumatic aortic transection (TRANSFIX)

Principal Investigator: Ali Khoynezhad, MD
IRB Approval Number: 30915
Contact: Anila Saeed: 424-315-4431
Status: Follow-up

Summary:
The Transfix transection study is a phase III stent graft trial. Any patient with an acute, traumatic aortic transection due to blunt injury is eligible for enrollment in the study. 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 safety and effectiveness of the Zenith® Endovascular System in the treatment of patients with aortic transection.

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