Clinical Trials

Principal Investigator: George Koullias, MD

Venous leg ulcers (VLUs) are defined as open lesions between the knee and ankle joint that occur in the presence of venous disease. They are the most common cause of leg ulcers, accounting for 60-80% of them. The prevalence of VLUs is between 0.18% and 1%. Over the age of 65, the prevalence increases to 4%. On an average 33-60% of these ulcers persist for more than 6 weeks and are therefore referred to as chronic VLUs. These ulcers represent the most advanced form of chronic venous disorders like varicose veins and lipodermatosclerosis.

Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM). Like native amniotic membrane, Affinity contains epithelial cells, fibroblasts, and mesenchymal stem cells. Affinity may be applied as a wound covering to a variety of partial- and full-thickness acute and chronic wounds.

This prospective, randomized, controlled trial will test whether the treatment group (Affinity plus standard of care) compared to the control group (standard of care alone) demonstrates statistically significant differences for time to and frequency of complete wound closure. It is hypothesized, based upon data obtained from both pre-clinical and clinical reporting, that Affinity may be effective in improving wound closure in a venous leg ulcer patient population with non-healing ulcers

Principal Investigator: Apostolos Tassiopoulos, MD

Historically, Abdominal Aortic Aneurysms (AAA) have been addressed via open surgical procedures that were more invasive and carried risks, especially in patients with comorbidities. To address this issue, alternative, less-invasive and more successful methods have been developed. These methods led to the introduction in 1991 of stent-grafts, which proved to be safer, and more effective in fixing AAAs, along with reducing hospital stay, complications, blood loss, as well as mortality and morbidity.

The TREO IDE stent-graft study assesses the safety and clinical outcomes in patients with infrarenal AAA, with or without iliac artery involvement. It is open to adults with Infrarenal Abdominal Aortic Aneurysms (AAA) and Aortoiliac Aneurysms, who require treatment with the TREO Abdominal Stent-Graft System. All subjects who meet the eligibility criteria, will be treated with the TREO Abdominal Stent-Graft System and will be followed-up for 5 years.

Principal Investigator: Antonios Gasparis MD

Chronic venous insufficiency (CVI), an advanced stage of chronic venous disease, is a common problem occurring in approximately 1-5% of the adult population. CVI can be caused by a nonthrombotic (primary) or postthrombotic (secondary) stimulus that involves reflux, obstruction, or a combination of both. The American Venous and Lymphatic Society recommends venous balloon angioplasty and stenting for treatment of nonthrombotic and postthrombotic iliac and common femoral venous obstructions in subjects with lower extremity pain or edema affecting quality of life (QOL) that cannot be palliated by compression. Stenting is also recommended for subjects with impending or active lower extremity venous leg ulceration caused by obstruction. Stent placement has a high technical success rate and effectiveness. Technical success of stent placement has been reported to be 84-93% in chronic postthrombotic iliac vein obstruction and clinical improvements in patients appears to be long lasting.

The Vesper DUO™ Venous Stent System is a new purpose-built stent system that will be studied for use in treating iliac and common femoral vein obstructions due to either nonthrombotic or postthrombotic etiology. The DUO™  Venous Stent System is manufactured by Vesper Medical, Inc. and consists of a primary hybrid stent designed for treating the iliac vein and an extension stent designed for extending treatment into the common femoral vein. Subjects may be treated with the hybrid stent alone or the hybrid stent and extension stent together.

Principal Investigator: Antonios Gasparis MD

The Post-Thrombotic Syndrome (PTS) is a frequent (40%) chronic complication of lower extremity deep vein thrombosis (DVT). Many patients experience PTS as some combination of chronic leg heaviness, fatigue, swelling, aching, and paresthesia that can be managed with modest lifestyle changes (e.g. rest periods with leg elevation). Disabling (moderate-to-severe) PTS, on the other hand, occurs in approximately 50% of patients who develop PTS and produces physical limitations comparable to severe chronic conditions such as chronic obstructive pulmonary disease and rheumatoid arthritis, resulting in work disability, inability to perform household tasks, and major impairment of health-related quality of life. In clinical practice, patients with disabling PTS frequently have chronic iliac vein obstruction (from previous iliac vein thrombosis orstenosis). Such patients with “disabling iliac-obstructive PTS” or “DIO-PTS” are especially prone to: 1) severe, short-distance venous claudication with “bursting” pain, necessitating cessation of walking or exercise, 2) massive edema that, because it involves the thigh as well as the calf, is markedly restrictive to activity and less amenable to relief with compression therapy, 3) chronic pain syndromes that often prompt chronic use of pain medications, and 4) venous ulcers that profoundly impair the quality of life, cause local and systemic infection, and/or require surgical therapy.

Principal Investigator: Antonios Gasparis MD

Principal Investigator: Adam Singer MD 

The Post-Thrombotic Syndrome (PTS) is a frequent (40%) chronic complication of lower extremity deep vein thrombosis (DVT). Many patients experience PTS as some combination of chronic leg heaviness, fatigue, swelling, aching, and paresthesia that can be managed with modest lifestyle changes (e.g. rest periods with leg elevation). Disabling (moderate-to-severe) PTS, on the other hand, occurs in approximately 50% of patients who develop PTS and produces physical limitations comparable to severe chronic conditions such as chronic obstructive pulmonary disease and rheumatoid arthritis, resulting in work disability, inability to perform household tasks, and major impairment of health-related quality of life. In clinical practice, patients with disabling PTS frequently have chronic iliac vein obstruction (from previous iliac vein thrombosis orstenosis). Such patients with “disabling iliac-obstructive PTS” or “DIO-PTS” are especially prone to: 1) severe, short-distance venous claudication with “bursting” pain, necessitating cessation of walking or exercise, 2) massive edema that, because it involves the thigh as well as the calf, is markedly restrictive to activity and less amenable to relief with compression therapy, 3) chronic pain syndromes that often prompt chronic use of pain medications, and 4) venous ulcers that profoundly impair the quality of life, cause local and systemic infection, and/or require surgical therapy.

Principal Investigator: Apostolos Tassiopoulos, MD

Co-Investigators: Angela Kokkosis, MD (link to her page)
                              Shang Loh, MD (formerly a physician in this department)    

Brief Description: Aortic aneurysmal disease is characterized by structural dysfunction of the aortic wall, with gradual expansion that can progress to rupture of the abdominal aorta. The goal of aortic aneurysm repair is to prevent aneurysm rupture and aneurysm-related death. There are two options for the treatment of aneurysms; traditional open surgery and endovascular repair. Open surgical repair, a procedure developed in the 1950s, is associated with the risks of morbidity and mortality inherent in any major invasive surgical procedure.

Endovascular aneurysm repair (EVAR) emerged in the early 1990s as an alternative, minimally invasive
treatment option. Endovascular device technology evolved rapidly to become an important treatment option for aortic aneurysm and is now more frequently employed than traditional open surgery. Endovascular repair is performed by inserting a delivery sheath containing the constrained endograft through the femoral artery to the level of the aneurysm. The sheath is retracted and the endograft is deployed. The aneurysm sac is excluded from arterial blood flow as the endograft expands against the arterial wall and seals proximally at the aortic neck and distally within the iliac arteries.

The Heli-FX™ EndoAnchor System was developed to address inadequate fixation and sealing of an
endograft. Securing the endograft to the aortic wall mimics a surgically sutured anastomosis, with the
goal of improving the adequacy of fixation and sealing. This goal attains particular importance in
subjects with short or angulated proximal aortic necks, where the risk of problems has been shown to
be increased over that of subjects with less hostile anatomy.

The objective of the ANCHOR registry is to expand the clinical knowledge based on the use of the Heli-
FX™ EndoAnchor System. This registry will include “real world” use over a broad spectrum of
geographies, by a wide variety of practicing clinicians, and with a minimal degree of subject selection
criteria.

Clinical Trial Identifier Number: NCT01534819, ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry) - Full Text View - ClinicalTrials.gov

Contact: Victoria.Boufis@stonybrookmedicine.edu

Title: Venous stent for the Iliofemoral Vein Investigational clinical trial using the DUO™ Venous Stent System (VIVID)

Principal Investigator: Apostolos Tassiopoulos, MD

Co-Investigators: Angela Kokkosis, MD
                              Shang Loh, MD  

Brief Description: Historically, abdominal aortic aneurysms have been repaired via open surgical repair. This procedure involves an incision in the abdomen to expose the aorta.  Then the diseased segment is replaced with a synthetic graft (typically polyester fabric) which is stitched in place in the aorta, excluding the aneurysm from further blood flow.  The procedure typically takes 3 to 6 hours and the hospital stay is usually 5 to 8 days.  Open repair, although effective in preventing rupture, is invasive and can be associated with significant morbidity rates, especially in high risk subjects.

Because of the desire for less invasive methods of treating aneurysms, alternative methods have been developed.  In 1991, Parodi et al reported on a successful treatment of AAA via stent-graft placement.  Stent-grafts are devices constructed of graft material supported by a metallic scaffold (stents) composed of nitinol, stainless steel, or cobalt chromium.  These devices are compressed inside a catheter-based delivery system so that rather than making a large abdominal incision to expose the diseased aorta, the device can be introduced into the vascular system through a small incision in the groin, advanced through the vasculature to the treatment site, and then deployed.  Like the surgical graft, the stent-graft creates a new channel while at the same time shielding the aneurysm from blood flow and further expansion.  

The Treovance Stent-Graft with Navitel Delivery System is intended for the treatment of infrarenal abdominal aortic aneurysms, with or without iliac artery involvement. The Treovance Stent-Graft consists of a main bifurcated device and two leg components, each delivered endovascularly and using its own separate delivery system. Additionally, radiopaque markers (Platinum/Iridium) are sewn in strategic places on the stent-graft to aid in the visualization and accurate placement of the device.

Clinical Trial Identifier Number: NCT02009644, Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms - Full Text View - ClinicalTrials.gov

Contact: Andrew.bryan@stonybrookmedicine.edu