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Research Trials in the Center for Vascular Disease

Researchers in Northwestern Memorial Hospital's Center for Vascular Disease at the Bluhm Cardiovascular Institute are conducting clinical research trials to learn more about treating vascular disease.

Clinical research trials search for new and better ways to understand and treat disease. Participating in a clinical research trial is an informative learning experience for the volunteer. Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge.  The following clinical research trial(s), specific to vascular disease, are currently recruiting volunteers:

Marrow Stim™ PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects with Severe Peripheral Arterial Disease (PAD)

Principal Investigator:
Melina R Kibbe, MD (profile opens in new window)
IRB Project Number:
STU00089609
Description of Research Trial:

This study is looking to enroll subjects with poor blood flow to the legs caused by severe peripheral arterial disease (PAD). Patients with PAD may experience pain in the foot, death of foot tissue, and/or infection in the foot. In addition, patients may eventually require an amputation of the foot, amputation of the leg below the knee, or amputation of the leg above the knee. The standard treatments for severe PAD are surgical bypass (insertion of a vein or synthetic graft to redirect blood flow around the blockage) and angioplasty (insertion of a balloon through the artery to open the blockage).  These standard treatments may not be an option for all patients due to the location and extent of the blockage in the leg. In this study, researchers will try to create new blood vessels (a process called angiogenesis) in the leg using cells obtained from patient’s own bone marrow.

The purpose of this study is to determine the safety and effectiveness of the MarrowStim PAD Kit (“study device”), which is an investigational device. The term investigational device means the device is not approved by the Food and Drug Administration (FDA). The study device is used to separate and concentrate certain cells from bone marrow, which will be drawn from the hip bones and then into separator tubes. The separator tubes are then placed into a machine that spins the tubes (a centrifuge), allowing the bone marrow to concentrate into different layers. One of these layers contains stem cells and it is this layer that is used in the investigational treatment to treat patients with severe PAD.

Subjects meeting study criteria will be randomly assigned (like flipping a coin) to one of two groups -either the MarrowStimTM active treatment group or the placebo control group.  Three out of every four (75%) of the subjects in this study will receive injections of cells that were separated from their bone marrow by the MarrowStim device – this is called the active treatment group.   One out of every four (25%) of the subjects in this study will receive needle punctures that will simulate injections, but no substance will be injected – this is called the placebo control group. The placebo treatment does not contain any concentrated bone marrow stem cells. All subjects will receive approximately 40 needle punctures to their diseased leg, but only the active treatment group will receive concentrated bone marrow stem cell injections.

The duration of the study is 52 weeks. Subjects assigned to the placebo control group who complete the 52 week study period, and if the study leg still meets the study criteria, may be eligible to receive the investigational treatment to their study leg with the concentrated bone marrow stem cells. This is called crossover treatment.

The study requires subjects to return to the study doctor for follow-up at day 1 and weeks 6, 12, 24, 36 and 52 post-treatment.  The study treatment procedure will be covered by the study sponsor and compensation will be provided to help cover time and travel expenses.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Dan Roshevsky at (312) 695-3264 or e-mail droshevs@nmh.org or Anna Karas at (312)695-2928 or e-mail akaras@nmh.org

EXCLUDER: Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms

Principal Investigator:
Andrew Hoel, MD (profile opens in new window)
IRB Project Number:
STU00083471
Description of Research Trial:

The GORE® EXCLUDER® study is recruiting patients who have an aneurysm in their common iliac artery. The primary alternative to participating in this study and undergoing the study procedure with the Study Device is open surgical repair of the aneurysm.   

Extensions of Stent grafts from the sponsor and other manufacturers are commercially-available and are alternative treatments for aneurysm treatment.  The benefits and risks of these devices are similar to those expected with the Study Device.  There are also surgical/endovascular procedures that may be performed in order establish blood flow to the diseased artery.”

The purpose of this Research Study is to determine the safety and effectiveness of the GORE® EXCLUDER® Iliac Branch Endoprosthesis (Study Device) when used for treatment of Common Iliac Artery Aneurysms (CIAA) or Aorto-iliac Aneurysms.

The Study Device consists of two pieces; the main Iliac Branch Component and the Internal Iliac Component.  The components are in the shape of a tube.  These components are folded tightly onto a catheter (a flexible, hollow tube) that is put into your common iliac artery through an artery in your leg. The GORE® EXCLUDER® Endoprosthesis (not investigational) and Study Device will block the injured part of the artery wall from the circulatory system and help maintain blood flow below the injury.

The Study Device is considered investigational, which means it has not yet been approved by the U.S. Food and Drug Administration (FDA).

Information will be collected on the performance of the Study Device for up to five (5) years.

Patients will be asked to come to Northwestern before their procedure, for their procedure and return to the Study Doctor’s office at one (1), six (6), 12, 24, 36, 48 and 60 months following the procedure for follow-up exams.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Julie Blaisdell at (312) 695-3410 or e-mail jblaisde@nmh.org or Anna Karas at (312)695-2928 or e-mail akaras@nmh.org

‘GREAT’ Global Registry for Endovascular Aortic Treatment Outcomes Evaluation

Principal Investigator:
Mark K. Eskandari, MD (profile opens in new window)
IRB Project Number:
STU00078308
Description of Research Trial:

The GREAT study is an observational data collection study called a registry. The goal of this registry is to collect information on individuals treated with endovascular grafts, which are devices delivered through a tube or catheter into an artery or vein to repair blood vessels.  The information collected will be used for reporting any positive or negative effects on the use of these devices in subjects from the time of treatment through up to 10 years of follow-up.  The registry team hopes to learn more about the performance of these devices in subjects over time in order to improve the care of people who receive endovascular grafts.

The study investigators hope to enroll 40 subjects at Northwestern University and 2,500 nationwide. 

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Julie Blaisdell at (312) 695-3410 or e-mail jblaisde@nmh.org 

GORE® TIGRIS® Vascular Stent Clinical Study

Principal Investigator:
Mark K. Eskandari, MD (profile opens in new window)
IRB Project Number:
STU000076468
Description of Research Trial:

The GORE® TIGRIS® Vascular Stent Clinical Study is recruiting participants who have been diagnosed with obstructive peripheral artery disease ("PAD"). The standard treatment for this condition is the insertion of a permanently implanted, self-expanding, vascular stent ("stent") to hold the blockage in the leg open. 

The purpose of this Study is to determine the safety and effectiveness of the GORE®  TIGRIS® Vascular Stent (the "Study Device") when used to treat patients with obstructive peripheral artery disease (PAD).

The Study Device is a self-expanding vascular stent. Vascular stents are hollow tube-like devices that expand to hold open blockages in arteries. The Study Device is made by forming a wire into a zigzag pattern, and then winding it into a hollow tube shape. The wire is covered with a flexible polymer film (a plastic-like material), with bridges of the polymer connecting adjacent rows of wire in the tube to maintain their even spacing. A small amount of heparin, a drug used to prevent blood clots, is permanently attached to the surfaces of the tube.  

The Study Device is considered investigational, which means it has not yet been approved by the U.S. FDA.

Your participation in this study would last three (3) years.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Julie Blaisdell at (312) 695-3410 or e-mail jblaisde@nmh.org 

Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT)

Principal Investigator:
William H Pearce, MD (profile opens in new window)
IRB Project Number:
STU00071910
Description of Research Trial:

This study is recruiting subjects that have been diagnosed with an abdominal aortic aneurysm.  An abdominal aortic aneurysm is when the large blood vessel (aorta) that supplies blood to the abdomen, pelvis, and legs becomes abnormally large or bulges outward. Small bulges can stay the same size for a time; most grow slowly; some grow quickly. No one knows exactly why there are these differences. When a small bulge is present, the usual course is to check its size every 6 months to see if it enlarges to a size that should be fixed. If the bulge grows to this larger size, there is a danger it will burst, which would be a threat to your life. Your doctors would recommend fixing the bulge if it becomes large enough to pose a risk to you.

The purpose of this study is to determine the effects of a medicine called doxycycline (“study medicine”) compared to placebo (an inactive pill) on the growth of this blood vessel bulge. If the study medicine slows the growth of the bulge in blood vessels, in future years it could be used to prevent the need for surgery or repair to the blood vessel.  It is thought that doxycycline may block an enzyme that acts to take apart proteins in the bulge wall.

The time it might take for the bulge to reach this large size could be short (6 months) or long (years). Because bulge growth varies, it can be hard to tell if a new medicine really works. To find out if the study medicine can slow the growth, we have to test it along with a matching placebo (inactive) capsule. Because these bulges typically grow at a slow rate, we will need to follow the growth for 2-3 years to see if there is a difference.

The study medicine, doxycycline, is approved by the Food and Drug Administration (FDA) for treatment of certain bacterial infections (antibiotic). However, use of the doxycycline in this study is experimental since the research study is trying to determine if it can slow or stop the growth of abdominal aortic aneurysms.

Subjects will be asked to return for follow-up visits every three (3) months for a minimum of 2 years or a maximum of 3.5 years.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Julie Blaisdell at (312) 695-3410 or e-mail jblaisde@nmh.org 

SAPPHIRE WW - Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy

Principal Investigator:
Mark K. Eskandari, MD (profile opens in new window)
IRB Project Number:
STU00018716
Description of Research Trial:

This study is enrolling patients who will be undergoing carotid stent supported angioplasty using PRECISE® Stent System and ANGIOGUARD™ XP/RX.  This procedure treats a narrowed artery in the neck called the carotid artery, which supplies blood to the brain.  This condition has either produced symptoms that include small strokes, or if without symptoms, could cause a future stroke.

Carotid stent supported angioplasty is an approved procedure being offered as an alternative to carotid artery surgery for narrowed carotid arteries.  Angioplasty (a balloon catheter technique) is an effective method of opening the blood vessels in the heart and legs.  A stent is a mettalic device that behaves like a spring to keep the artery open.  The devices that will be used are the Cordis PRECISE® Nitinol Stent System and the Cordis ANGIOGUARD™ XP/RX Emboli Capture Guidewire (ECGW).  Both of these devices have been approved by the Food and Drug Administration (FDA).  Other PRECISE® stents that are approved for use by the FDA in the future may also be used.

This study will collect information about the devices in 15,000 patients in North America.  Approximately 70 patients will participate at Northwestern University.

Research Trial Contact Information:
For more information, interested participants and clinicians may contact Julie Blaisdell at (312) 695-3410 or e-mail jblaisde@nmh.org 
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This page last updated 

March 17, 2014
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Bluhm Cardiovascular Institute - Clinical Trials Unit (CTU)
Feinberg School of Medicine
676 North Saint Clair Street, Suite 1700
Chicago, IL 60611-2969
Phone: (312) 926-4000
Email: heartresearch@northwestern.edu

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