Clinical Trials

The Department has one of the world’s largest aortic surgery practices and as such is a major center for device development research.  There are a number of ongoing clinical trials at various stages of recruitment, enrollment, and completion.

Active Clinical Trials

A randomized controlled comparative study on effectiveness of endovascular repair versus best medical therapy for acute uncomplicated Type B aortic dissection. (ACUTE-B)
PI: Sandhu
Status: Active & Enrolling
Synopsis: Randomized Controlled Trial for patients who present with Acute Uncomplicated Type B Aortic Dissection. Single Center Trial.

ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
PI: Estrera
Status: Enrolling & Follow-Up
Synopsis: Endovascular treatment of patients with DeBakey Type A Aortic Dissection with Gore Ascending Stent Graft, Feasibility Sponsored Trial.

BEST-CLI (Randomized, Multicenter, Controlled Trial to Compare Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia)
PI: Khan
Status: Active & Enrolling
Synopsis: This National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) sponsored study is designed to evaluate the effectiveness of best endovascular (EVT) compared to best surgical (OPEN) revascularization in patients with CLI

Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections with Fenestrated and Branched Stent Grafts
PI: Oderich
Status: Active & Enrolling

CRYOICE STUDY
PI: Estrera
Status: Enrolling & Follow-Up
Synopsis: The primary objective of the study is to prove the feasibility of intercostal nerve cryoablation in postoperative pain control both in magnitude and duration in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.

Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
PI: Khan
Status: Enrolling & Follow-Up
Synopsis: Endovascular treatment for patients who require coverage of aortic branch vessels to treat aortic dissection, aortic aneurysms, or Traumatic Aortic Injuries. Multi-center sponsored clinical trial.

GREAT (Global Registry for Endovascular Aortic Treatment Outcomes Evaluation)
PI: Afifi
Status: Follow-Up
Synopsis: A registry to capture data on individuals with endovascular grafts.  Multi-center sponsored clinical trial.

Intercostal Nerve Cryoablation for Postoperative Pain Management
PI: Estrera
Status: Active & Enrolling
Synopsis: Prospective single-blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design. The primary objective of the study is to prove the feasibility of intercostal nerve cryoablation in postoperative pain control both in magnitude and duration in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.

ON-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
PI: Nguyen
Status: Enrolling & Follow-Up
Synopsis: A registry to examine the performance of the On-X aortic valve using warfarin.  Multi-center sponsored clinical trial.

Relay-Pro
PI: Saqib
Status: Enrolling & Follow-Up
Synopsis: Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro in Subjects with Acute, Complicated Type B Aortic Dissections

SAFE (Strategy for Active Follow-up Evaluation)
PI: Estrera and Charlton-Ouw
Synopsis: A prospective study to track outcomes and surveillance of patients after arterial reconstructions.

STABILISE REGISTRY (STABIL.REG.)
PI: Oderich
Status: Active & Enrolling
Synopsis: A physician-initiated, international, multi-center, prospective and retrospective, non-randomized, observational registry of patients with acute/subacute type B aortic dissection treated by means of the STABILISE technique

SURE
PI: Nguyen
Status: Follow-Up
Synopsis: Sorin Universal Registry on Aortic Valve Replacements; The purpose is to collect safety and clinical performance post market data related to the Sorin Group aortic valve devices

TAMBE (The GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis)
PIs: Estrera and Smalling
Status: Active & Enrolling
Synopsis: TAMBE is intended for endovascular repair of thoracoabdominal and pararenal aortic aneurysms in patients with appropriate anatomy.

TAVR (Trans-aortic aortic valve replacement)
PIs: Estrera and Smalling
Status:
Synopsis: This study randomizes patients to either percutaneous aortic valve replacement or standard open surgical repair

Thoraflex Hybrid IDE
PI: Estrera
Status: Follow-Up
Synopsis: A prospective study assessing the safety and clinical outcomes of the Thoraflex Hybrid Device in the treatment of aortic disease affecting the aortic arch and the descending thoracic aorta.

VIEW-VLU: Observational Study of the Effect of Varithena on Wound Healing in the Treatment of Venous Leg Ulcers Resulting from Chronic Venous Insufficiency.
PI: Harlin
Status: Follow-Up
Synopsis:  Registry analyzing changes in chronic venous ulcers and quality of life after treatment of veins with Varithena (Polidocanol 1%) foam.

Recently Completed Clinical Trials

(Last Updated: August, 2020)